Cervical AdenocarcinomaNCT01992861
MRI and PET Imaging in Predicting Treatment Response in Patients With Stage IB-IVA Cervical Cancer
An observational study of Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by University of Washington at 6 sites in 3 countries.
Trial summary
This trial studies magnetic resonance imaging (MRI) and positron emission tomography (PET) imaging in predictive treatment response in patients with stage IB-IVA cervical 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 Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified
- What is being tested?
- Computed Tomography, Diffusion Weighted Imaging and Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 14 Feb 2014to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, who will undergo radiation therapy for cervical cancer with curative intent.
Who may be able to join
- Patients must have histologically confirmed stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, and excluding small cell/neuroendocrine carcinoma, who will undergo radiation therapy for cervical cancer with curative intent
- Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
- Patients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancer
- Patients with no prior radiation therapy to the pelvis
- Patients with no contra-indications to magnetic resonance (MR) imaging
- Patients must have adequate renal function: glomerular filtration rate (GFR) > 30 mL/min/1.73 m^2; for the test-retest sub-study MRI, patients must have a GFR of > 60 mL/min/1.73m^2
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with small cell/neuroendocrine cervical carcinoma
- Patients who have received any prior pelvic radiation therapy in the area of the tumor that precludes the delivery of a curative dose of pelvic radiation
- Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds, GFR < 30)
- Major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment, completion of the study protocol, or interfere with follow-up
- Life expectancy of less than 6 months
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Loyola University Medical Center
Maywood, Illinois, 60153
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: MRI- and PET-Predictive-Assay of Treatment Outcome in Cancer of the Cervix
This trial studies magnetic resonance imaging (MRI) and positron emission tomography (PET) imaging in predictive treatment response in patients with stage IB-IVA cervical cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. PET is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Comparing results of diagnostic procedures, such as MRI and PET, done before, during and after radiation and chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
Read the detailed description
OUTLINE:
Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo dynamic contrast-enhanced (DCE) MRI, diffusion-weighted (DW) MRI, and magnetic resonance (MR) spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and fludeoxyglucose F 18 (FDG) PET/computed tomography (CT) at baseline, 2-2.5 weeks, and 4-5 weeks.
After completion of study, patients are followed up at least every 3-6 months for 5 years.
- Conditions
- Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Cervical Undifferentiated Carcinoma, Recurrent Cervical Carcinoma, Stage IB2 Cervical Cancer
- Being tested
- Computed Tomography, Diffusion Weighted Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Fludeoxyglucose F-18, Magnetic Resonance Spectroscopic Imaging
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo FDG PET/CT
Diffusion Weighted ImagingProcedure or surgery
Also called Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI
Undergo DW MRI
Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Undergo DCE MRI
Fludeoxyglucose F-18Radiation
Also called 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18
Undergo FDG PET/CT
Magnetic Resonance Spectroscopic ImagingProcedure or surgery
Also called 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS
Undergo MR spectroscopy
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan
Undergo FDG PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT) | Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo DCE MRI, DW MRI, and MR spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and FDG PET/CT at baseline, 2-2.5 weeks, and 4-5 weeks. Receives: Procedure: Computed Tomography; Procedure: Diffusion Weighted Imaging; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Radiation: Fludeoxyglucose F-18; Procedure: Magnetic Resonance Spectroscopic Imaging; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: Up to 5 years
Distant metastatic rate
Measured: Up to 5 years
Local control
Clinical/pelvic examination, pap smear, other standard of care investigations as indicated by clinical findings.
Measured: Up to 5 years
Predictive power of the MRI and PET/CT parameters
Hazard ratios will be calculated. Predictive power of the heterogeneity metrics will be compared and ranked with Federation of Gynecology and Obstetrics stage, lymph node status, histology, hemoglobin level, and tumor anatomic volumes. Multivariate predictive algorithms will be derived by synergizing the predictive power of imaging metrics and clinical prognosticators for clinical translation.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study start14 Feb 2014
- Primary completionJan 2022
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Simon Lo, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992861
- Sponsor's protocol ID
- 8118
- Other IDs
- NCI-2013-01935, 8118, R01CA155454, RG3114003
- Status last verified
- Jun 2023
- First submitted
- 5 Nov 2013
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI- and PET-Predictive-Assay of Treatment Outcome in Cancer of the Cervix
- ClinicalTrials.gov ID
- NCT01992861
- Acronym / sponsor ID
- 8118
- Conditions
- Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Cervical Undifferentiated Carcinoma, Recurrent Cervical Carcinoma, Stage IB2 Cervical Cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 14 Feb 2014
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies magnetic resonance imaging (MRI) and positron emission tomography (PET) imaging in predictive treatment response in patients with stage IB-IVA cervical cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. PET is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Comparing results of diagnostic procedures, such as MRI and PET, done before, during and after radiation and chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
Detailed description
OUTLINE:
Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo dynamic contrast-enhanced (DCE) MRI, diffusion-weighted (DW) MRI, and magnetic resonance (MR) spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and fludeoxyglucose F 18 (FDG) PET/computed tomography (CT) at baseline, 2-2.5 weeks, and 4-5 weeks.
After completion of study, patients are followed up at least every 3-6 months for 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT) | – | Procedure: Computed Tomography, Procedure: Diffusion Weighted Imaging, Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Radiation: Fludeoxyglucose F-18, Procedure: Magnetic Resonance Spectroscopic Imaging, Procedure: Positron Emission TomographyPatients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo DCE MRI, DW MRI, and MR spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and FDG PET/CT at baseline, 2-2.5 weeks, and 4-5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, who will undergo radiation therapy for cervical cancer with curative intent.
Key inclusion criteria (7 listed)
- Patients must have histologically confirmed stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, and excluding small cell/neuroendocrine carcinoma, who will undergo radiation therapy for cervical cancer with curative intent
- Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
- Patients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancer
- Patients with no prior radiation therapy to the pelvis
- Patients with no contra-indications to magnetic resonance (MR) imaging
Key exclusion criteria (5 listed)
- Patients with small cell/neuroendocrine cervical carcinoma
- Patients who have received any prior pelvic radiation therapy in the area of the tumor that precludes the delivery of a curative dose of pelvic radiation
- Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds, GFR < 30)
- Major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment, completion of the study protocol, or interfere with follow-up
- Life expectancy of less than 6 months
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 |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo FDG PET/CT | Procedure or surgery | Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT) |
| Diffusion Weighted ImagingAlso: Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRIUndergo DW MRI | Procedure or surgery | Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT) |
| Dynamic Contrast-Enhanced Magnetic Resonance ImagingAlso: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRIUndergo DCE MRI | Procedure or surgery | Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT) |
| Fludeoxyglucose F-18Also: 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18Undergo FDG PET/CT | Radiation | Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT) |
| Magnetic Resonance Spectroscopic ImagingAlso: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRSUndergo MR spectroscopy | Procedure or surgery | Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography ScanUndergo FDG PET/CT | Procedure or surgery | Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT) |
Primary outcome
Disease-free survival
Time frame: Up to 5 years
Distant metastatic rate
Time frame: Up to 5 years
Local control
Time frame: Up to 5 years
Clinical/pelvic examination, pap smear, other standard of care investigations as indicated by clinical findings.
Predictive power of the MRI and PET/CT parameters
Time frame: Up to 5 years
Hazard ratios will be calculated. Predictive power of the heterogeneity metrics will be compared and ranked with Federation of Gynecology and Obstetrics stage, lymph node status, histology, hemoglobin level, and tumor anatomic volumes. Multivariate predictive algorithms will be derived by synergizing the predictive power of imaging metrics and clinical prognosticators for clinical translation.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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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.
Simon Lo principal investigator
Fred Hutch/University of Washington Cancer Consortium
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by University of Washington at 6 sites in 3 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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada, Hong Kong. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Disease-free survival (time frame: Up to 5 years). The study lists 4 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 26 Jun 2023.