Cervical AdenocarcinomaPhase 1/2NCT00416455
Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer
A Phase 1/2 study testing fludeoxyglucose F 18, positron emission tomography and computed tomography in people with Cervical Adenocarcinoma and Cervical Adenosquamous Cell Carcinoma, run by National Cancer Institute (NCI) at 33 sites in 4 countries.
Trial summary
This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Small Cell Carcinoma
- What is being tested?
- fludeoxyglucose F 18, positron emission tomography and computed tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 33 sitesin 4 countries
- Study dates
- Sep 2007to 16 Jul 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of 1 of the following:
- Invasive carcinoma of the cervix meeting all of the following criteria:
- Previously untreated, primary disease
- Locoregionally advanced (stage IB2, IIA [>= 4 cm], or IIB-IVA) disease
- Any cell type allowed
- High-risk endometrial carcinoma meeting 1 of the following criteria:
Show all 38Show fewer
- Grade 3 endometrioid or non-endometrioid endometrial carcinoma (clear cell or serous papillary) or carcinosarcoma diagnosed from an endometrial biopsy or dilation and curettage or
- Grade 1 or 2 endometrioid endometrial carcinoma with cervical stromal involvement overt on clinical examination or confirmed by endocervical curettage
- Under consideration for chemoradiotherapy (patients with cervical cancer)
- Undergone appropriate surgery for cervical or endometrial carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
- Appropriate surgical candidate to undergo extraperitoneal or laparoscopic lymph node sampling OR hysterectomy and lymph node sampling
- No surgery for patients with advanced lymphadenopathy
- No recurrent invasive carcinoma of the uterus or uterine cervix regardless of previous treatment
- No known metastases to the lungs or scalene lymph nodes
- No metastases to other organs outside of the pelvis or abdominal lymph nodes at the time of the original clinical diagnosis
- Patients with endometrial cancer with known intraperitoneal disease are eligible provided they undergo pelvic and para-aortic lymphadenectomy per protocol
- Participants must be enrolled at an American College of Radiology Imaging Network (ACRIN)-affiliated institution that is accredited by Gynecologic Oncology Group (GOG)
- GOG performance status 0-2
- Creatinine within normal institutional limits OR, in participants with creatinine levels above institutional normal, glomerular filtration rate (GFR) must be > 60 mL/min; there is no lower limit of normal for serum creatinine for this protocol
- Ferritin levels =< 600 ng/mL OR saturation of transferrin level =< 50%
- Patients with high levels of ferritin or transferrin are eligible if documented hematology rules out iron overload
- Not pregnant or nursing
- Negative pregnancy test
- No patients weighing greater than that allowable by the PET/CT scanner
- No renal abnormalities, such as a pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of the lymphadenectomy
- No history of anaphylactic or life-threatening allergic reactions to any contrast media
- No other invasive malignancies within the past 5 years with the exception of nonmelanoma skin cancer
- No contraindication to MRI (e.g., severe claustrophobia, pacemaker, aneurysm clips, defibrillators, or other institutional contraindication to MRI)
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to ferumoxtran-10 (e.g., iron preparations, parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations)
- No immunodeficiencies that would predispose patient to specific or nonspecific mediator release
- No history of cirrhosis
- No poorly controlled, insulin-dependent diabetes (i.e., fasting blood glucose level > 200 mg/dL)
- No prior pelvic or abdominal lymphadenectomy
- No prior pelvic radiotherapy
- No prior anticancer therapy that would contraindicate study participation
- No ferumoxides within the past 2 weeks
- No investigational agents within the past 30 days
- No other concurrent investigational agents
Who cannot join
None listed.
Trial locations and contacts
33 sites in 4 countries.
33 sites in 4 countries
United States24 sites
Georgia Regents University Medical Center
Augusta, Georgia, 30912
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Island Gynecologic Oncology
Brightwaters, New York, 11718
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Cincinnati
Cincinnati, Ohio, 45267
Case Western Reserve University
Cleveland, Ohio, 44106
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
University of California at Los Angeles Health System
Los Angeles, California, 90095
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Mount Sinai Medical Center
New York, New York, 10029
Weill Medical College of Cornell University
New York, New York, 10065
UMDNJ - New Jersey Medical School
Newark, New Jersey, 07103
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Providence Cancer Center -The Plaza
Portland, Oregon, 97213
Providence Portland Medical Center
Portland, Oregon, 97213
Women and Infants Hospital
Providence, Rhode Island, 02905
Mayo Clinic
Rochester, Minnesota, 55905
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Olive View-University of California Los Angeles Medical Center
Sylmar, California, 91342
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
South Korea5 sites
Keimyung University-Dongsan Medical Center
Jung-Ku, Daegu, 700-712
Seoul National University Hospital
Seoul, 110-744
Gangnam Severance Hospital
Seoul, 135-720
Asan Medical Center
Seoul, 138-736
Korea Cancer Center Hospital
Seoul, 139-706
Japan3 sites
Kagoshima City Hospital
Kagoshima City, Kagoshima, 892-8580
Saitama Medical University International Medical Center
Saitama, 350-1298
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
About this study
Official title: Utility of Preoperative FDG-PET/CT Scanning Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients With Locoregionally Advanced Carcinoma of the Cervix (IB2, IIA ≥ 4 CM, IIB-IVA) or Endometrium (Grade 3 Endometrioid Endometrial Carcinoma; Serous Papillary Carcinoma, Clear Cell Carcinoma, or Carcinosarcoma (Any Grade); and Grade 1 OR 2 Endometrioid Endometrial Carcinoma With Cervical Stromal Involvement Overt in Clinical Examination or Confirmed by Endocervical Curettage
This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or endometrial cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to abdominal (common iliac, para-aortic, and paracaval) lymph nodes in patients with locoregionally advanced cervical carcinoma.
II. Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to retroperitoneal abdominal lymph nodes in patients with high-risk endometrial cancer.
SECONDARY OBJECTIVES:
- Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to pelvic lymph nodes and pelvic and abdominal lymph nodes combined in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
II. Compare the additive diagnostic value of CT fusion (PET/CT scan) vs PET scanning alone in identifying metastases to pelvic, abdominal, and combined (all regions) lymph nodes in these patients.
III. Compare the diagnostic sensitivity and specificity of PET/CT scanning vs ferumoxtran-10 MRI scanning in identifying metastases to pelvic, abdominal, and combined lymph nodes in these patients.
IV. Compare the diagnostic sensitivity and specificity of ferumoxtran-10 MRI vs MRI alone, in terms of size criteria in the abdomen and pelvis, in these patients.
- Determine the percentage of patients with locoregionally advanced cervical cancer or high-risk endometrial cancer who have biopsy-proven disease outside the abdominal or pelvic lymph nodes detected by PET/CT scanning.
VI. Determine the accuracy of MRI in determining the depth of myometrial invasion and involvement of cervix in patients with high-risk endometrial cancer.
VII. Determine the complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer.
VIII. Determine the cause(s) of delay in the initiation of radiotherapy or interruption in radiotherapy in patients with locoregionally advanced cervical cancer.
IX. Collect data on the adverse effects of ferumoxtran-10 in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
- Compare the size of lymph nodes in pre- and post-ferumoxtran-10 MRI's in a subset of forty patients.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2. Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan.
After completion of study therapy, patients are followed at 6 weeks, 6 months, every 3 months for 2 years, and then every 6 months for 3 years.
- Conditions
- Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma
- Being tested
- fludeoxyglucose F 18, positron emission tomography, computed tomography, ferumoxtran-10, magnetic resonance imaging
- Medical subject headings
- Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fludeoxyglucose F 18Radiation
Also called 18FDG, FDG
Undergo FDG PET/CT
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo FDG PET/CT
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo FDG PET/CT
ferumoxtran-10Drug
Also called AMI-227, Combidex, G-53425, Sinerem
Undergo femoxtran-10 MRI
magnetic resonance imagingProcedure or surgery
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo femoxtran-10 MRI
diagnostic lymphadenectomyProcedure or surgery
Undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy
lymph node biopsyProcedure or surgery
Also called Biopsy of Lymph Node
Undergo pelvic and abdominal lymph node biopsy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (diagnostic scans, surgery, chemotherapy, radiation) | Experimental | Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2. Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan. Receives: Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography; Procedure: computed tomography; Drug: ferumoxtran-10; Procedure: magnetic resonance imaging; Procedure: diagnostic lymphadenectomy; Procedure: lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.
Measured: Before surgery (FDG-PET-CT) and after surgery (pathology)
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers.
Measured: Before surgery (FDG-PET/CT) and after surgery (pathology)
Secondary outcomes (15)
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported sensitivity is reader-averaged sensitivity.
Measured: Before surgery (DCT) and after surgery (pathology)
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
The specificity is defined as the percentage of patients who test without lymph node metastases in pelvis by pre-operative PET/CT among the patients who do not have lymph node metastases in pelvis identified by post-surgery pathology. The reported specificity is reader-averaged specificity.
Measured: Before surgery (FDG-PET/CT) and after surgery (pathology)
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported sensitivity is reader-average sensitivity.
Measured: Before surgery (FDG-PET/CT) and after surgery (pathology)
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported specificity is reader-averaged specificity.
Measured: Before surgery (FDG-PET/CT) and after surgery (pathology)
Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative CT alone among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Measured: Before surgery (FDG-PET/CT) and after surgery (pathology)
Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative either CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Measured: Before surgery (FDG-PET/CT) and after surgery (pathology)
Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative by CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Measured: Before surgery (FDG-PET/CT) and after surgery (pathology)
Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Measured: Before surgery (FDG-PET/CT) and after surgery (pathology)
Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative byCT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Measured: Before surgery (FDG-PET/CT) and after surgery (pathology)
Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Measured: Before surgery (FDG-PET/CT) and after surgery (pathology)
Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes
Measured: Before surgery (FDG-PET/CT) and after surgery (pathology)
Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node
Measured: Before surgery (FDG-PET/CT) and after surgery (pathology)
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Number of participants with cervical cancer and a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.
Measured: During surgery and up to 30 days after surgery.
Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients
Number of cervical cancer patients with reasons of delay in the initiation of chemo-radiation therapy
Measured: Within 4 weeks from PET/CT
Cause of Interruption in Radiation Therapy in Cervical Cancer Patients
Number of cervical cancer patients with reasons of interruption in radiation therapy
Measured: Within 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startSep 2007
- Primary completionSep 2014
- Study completion16 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- NRG Oncology
- Responsible party
- Sponsor
- Investigators
- Mostafa Atri, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416455
- Sponsor's protocol ID
- NCI-2009-00600
- Other IDs
- NCI-2009-00600, CDR0000521453, ACRIN 6671, GOG-0233/ACRIN 6671, GOG-0233-ACRIN 6671, GOG-0233, U10CA180868, U10CA027469
- Status last verified
- Nov 2018
- First submitted
- 27 Dec 2006
- Last updated
- 23 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Preoperative FDG-PET/CT Scanning Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients With Locoregionally Advanced Carcinoma of the Cervix (IB2, IIA ≥ 4 CM, IIB-IVA) or Endometrium (Grade 3 Endometrioid Endometrial Carcinoma; Serous Papillary Carcinoma, Clear Cell Carcinoma, or Carcinosarcoma (Any Grade); and Grade 1 OR 2 Endometrioid Endometrial Carcinoma With Cervical Stromal Involvement Overt in Clinical Examination or Confirmed by Endocervical Curettage
- ClinicalTrials.gov ID
- NCT00416455
- Acronym / sponsor ID
- NCI-2009-00600
- Conditions
- Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- NRG Oncology
- Study start
- Sep 2007
- Primary completion
- Sep 2014 (actual)
- Study completion
- 16 Jul 2016 (actual)
- First posted
- 28 Dec 2006 (estimated)
- Results
- Posted 14 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or endometrial cancer.
Detailed description
PRIMARY OBJECTIVES:
- Determine the diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to abdominal (common iliac, para-aortic, and paracaval) lymph nodes in patients with locoregionally advanced cervical carcinoma.
II. Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to retroperitoneal abdominal lymph nodes in patients with high-risk endometrial cancer.
SECONDARY OBJECTIVES:
- Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to pelvic lymph nodes and pelvic and abdominal lymph nodes combined in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
II. Compare the additive diagnostic value of CT fusion (PET/CT scan) vs PET scanning alone in identifying metastases to pelvic, abdominal, and combined (all regions) lymph nodes in these patients.
III. Compare the diagnostic sensitivity and specificity of PET/CT scanning vs ferumoxtran-10 MRI scanning in identifying metastases to pelvic, abdominal, and combined lymph nodes in these patients.
IV. Compare the diagnostic sensitivity and specificity of ferumoxtran-10 MRI vs MRI alone, in terms of size criteria in the abdomen and pelvis, in these patients.
- Determine the percentage of patients with locoregionally advanced cervical cancer or high-risk endometrial cancer who have biopsy-proven disease outside the abdominal or pelvic lymph nodes detected by PET/CT scanning.
VI. Determine the accuracy of MRI in determining the depth of myometrial invasion and involvement of cervix in patients with high-risk endometrial cancer.
VII. Determine the complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer.
VIII. Determine the cause(s) of delay in the initiation of radiotherapy or interruption in radiotherapy in patients with locoregionally advanced cervical cancer.
IX. Collect data on the adverse effects of ferumoxtran-10 in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
- Compare the size of lymph nodes in pre- and post-ferumoxtran-10 MRI's in a subset of forty patients.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2. Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan.
After completion of study therapy, patients are followed at 6 weeks, 6 months, every 3 months for 2 years, and then every 6 months for 3 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (diagnostic scans, surgery, chemotherapy, radiation) | Experimental | Radiation: fludeoxyglucose F 18, Procedure: positron emission tomography, Procedure: computed tomography, Drug: ferumoxtran-10, Procedure: magnetic resonance imaging, Procedure: diagnostic lymphadenectomy, Procedure: lymph node biopsyPatients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2. Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- Histologically or cytologically confirmed diagnosis of 1 of the following:
- Under consideration for chemoradiotherapy (patients with cervical cancer)
- Undergone appropriate surgery for cervical or endometrial carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
- Appropriate surgical candidate to undergo extraperitoneal or laparoscopic lymph node sampling OR hysterectomy and lymph node sampling
- No recurrent invasive carcinoma of the uterus or uterine cervix regardless of previous treatment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fludeoxyglucose F 18Also: 18FDG, FDGUndergo FDG PET/CT | Radiation | Treatment (diagnostic scans, surgery, chemotherapy, radiation) |
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo FDG PET/CT | Procedure or surgery | Treatment (diagnostic scans, surgery, chemotherapy, radiation) |
| computed tomographyAlso: tomography, computedUndergo FDG PET/CT | Procedure or surgery | Treatment (diagnostic scans, surgery, chemotherapy, radiation) |
| ferumoxtran-10Also: AMI-227, Combidex, G-53425, SineremUndergo femoxtran-10 MRI | Drug | Treatment (diagnostic scans, surgery, chemotherapy, radiation) |
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo femoxtran-10 MRI | Procedure or surgery | Treatment (diagnostic scans, surgery, chemotherapy, radiation) |
| diagnostic lymphadenectomyUndergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy | Procedure or surgery | Treatment (diagnostic scans, surgery, chemotherapy, radiation) |
| lymph node biopsyAlso: Biopsy of Lymph NodeUndergo pelvic and abdominal lymph node biopsy | Procedure or surgery | Treatment (diagnostic scans, surgery, chemotherapy, radiation) |
Primary outcome
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
Time frame: Before surgery (FDG-PET-CT) and after surgery (pathology)
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers.
15 secondary outcomes
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
Time frame: Before surgery (DCT) and after surgery (pathology)
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Time frame: During surgery and up to 30 days after surgery.
Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients
Time frame: Within 4 weeks from PET/CT
Cause of Interruption in Radiation Therapy in Cervical Cancer Patients
Time frame: Within 6 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa Atri principal investigator
NRG Oncology
33 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing fludeoxyglucose F 18, positron emission tomography and computed tomography in people with Cervical Adenocarcinoma and Cervical Adenosquamous Cell Carcinoma, run by National Cancer Institute (NCI) at 33 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, South Korea, Japan, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen (time frame: Before surgery (FDG-PET-CT) and after surgery (pathology)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.