Cervical CancerPhase 1NCT02285192
Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
A Phase 1 study testing 18F-Fluorodeoxyglucose (18F-FDG), PET/CT imaging and PET/MRI imaging in people with Cervical Cancer and Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose (18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer
- What is being tested?
- 18F-Fluorodeoxyglucose (18F-FDG), PET/CT imaging and PET/MRI imaging
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2014to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- The study population will include women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery, and women with a clinical stage I high-grade endometrial cancer planning to undergo surgical staging. High grade is defined by the following:
- Uterine serous carcinoma
- Clear cell endometrial carcinoma
- Grade 3 endometrioid carcinoma
- Endometrial carcinosarcoma
- Clinical stage I grade 1-2 endometrial cancer also eligible with deep myoinvasion ≥ 50% shown on preop MRI and/or elevated preop CA-125 > 35 U/ml.
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- Age ≥18 years
- Hemoglobin ≥10 g/dL
- Plasma albumin ≥3 g/dL
- GOG performance status ≤2
- Plasma glucose ≤200 mg/dL
- Plasma creatinine ≤1.6
- Well-controlled hypertension
- Medical clearance for surgery and considered an appropriate surgical candidate
- Negative serum pregnancy test, if of child-bearing potential
- If, based on surgeon's assessment, the patient is recommended to undergo surgical staging for histologically confirmed endometrial cancer or if IB1 cervical cancer is deemed eligible for surgical treatment of disease
- Participation in other research protocols does not exclude a patient from participation in this study
Who cannot join
- Hemoglobin <10 g/dL
- Plasma albumin <3 g/dL
- GOG performance status >2
- Plasma glucose >200 mg/dL
- Renal insufficiency with plasma creatinine >1.6
- Uncontrolled hypertension
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- Patient does not meet medical clearance for surgery and is not considered an appropriate surgical candidate
- Pregnancy
- For Stage 2:
- Patient who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers of non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
- Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent only)
Commack, New York
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553
About this study
The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose (18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain cancer.
- Conditions
- Cervical Cancer, Endometrial Cancer
- Being tested
- 18F-Fluorodeoxyglucose (18F-FDG), PET/CT imaging, PET/MRI imaging
- Keywords
- 18F-FDG Injection, Positron Lymphography, Lymphatic Mapping, sentinel lymph nodes, PET/CT, 14-222
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Fluorodeoxyglucose (18F-FDG)Radiation
PET/CT imagingDevice
PET/MRI imagingDevice
| Study group | Role | What they receive |
|---|---|---|
| intracervical 18F-FDG injection during a dynamic PET/CT | Experimental | The first 20 eligible patients will be consented to undergo intracervical 18F-FDG injection during a dynamic PET/CT scan. Study enrollment will occur in the clinic during the visit in which they are consented for surgery. Recruited patients will undergo 18F-FDG-guided PET imaging on the day of their scheduled staging surgery. The experimental PET/CT is anticipated to take 2 hours. The second stage of accrual will replace PET/CT with PET/MRI imaging. In every other aspect, patients will receive standard peri- and postoperative care. Receives: Radiation: 18F-Fluorodeoxyglucose (18F-FDG); Device: PET/CT imaging; Device: PET/MRI imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of Positron Lymphography
Accuracy of Positron Lymphography will be defined in terms of sensitivity and will consist of pathology review of labelled, excised specimens compared with lymph node imaging data acquired preoperatively.
Measured: 2 years
Secondary outcomes (1)
to evaluate several standard uptake value (SUV) (18F-FDG avidity)
will assess the ability of SUV to predict malignant disease. The continuous variable of SUV assigned to a given lymph node during Positron Lymphography will be compared with the pathologic assessment (benign vs malignant) of each labelled lymph node. The SUV assigned to a given lymph node is done using the the imaging software and not up to the discretion of the radiologist.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Mueller, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285192
- Sponsor's protocol ID
- 14-222
- Status last verified
- Dec 2025
- First submitted
- 4 Nov 2014
- Last updated
- 30 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02285192
- Acronym / sponsor ID
- 14-222
- Conditions
- Cervical Cancer, Endometrial Cancer
- Keywords
- 18F-FDG Injection, Positron Lymphography, Lymphatic Mapping, sentinel lymph nodes, PET/CT, 14-222
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 6 Nov 2014 (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.
The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose (18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intracervical 18F-FDG injection during a dynamic PET/CT | Experimental | Radiation: 18F-Fluorodeoxyglucose (18F-FDG), Device: PET/CT imaging, Device: PET/MRI imagingThe first 20 eligible patients will be consented to undergo intracervical 18F-FDG injection during a dynamic PET/CT scan. Study enrollment will occur in the clinic during the visit in which they are consented for surgery. Recruited patients will undergo 18F-FDG-guided PET imaging on the day of their scheduled staging surgery. The experimental PET/CT is anticipated to take 2 hours. The second stage of accrual will replace PET/CT with PET/MRI imaging. In every other aspect, patients will receive standard peri- and postoperative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- The study population will include women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery, and women with a clinical stage I high-grade endometrial cancer planning to undergo surgical staging. High grade is defined by the following:
- Age ≥18 years
- Hemoglobin ≥10 g/dL
- Plasma albumin ≥3 g/dL
- GOG performance status ≤2
Key exclusion criteria (11 listed)
- Hemoglobin <10 g/dL
- Plasma albumin <3 g/dL
- GOG performance status >2
- Plasma glucose >200 mg/dL
- Renal insufficiency with plasma creatinine >1.6
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 |
|---|---|---|
| 18F-Fluorodeoxyglucose (18F-FDG) | Radiation | intracervical 18F-FDG injection during a dynamic PET/CT |
| PET/CT imaging | Device | intracervical 18F-FDG injection during a dynamic PET/CT |
| PET/MRI imaging | Device | intracervical 18F-FDG injection during a dynamic PET/CT |
Primary outcome
diagnostic accuracy of Positron Lymphography
Time frame: 2 years
Accuracy of Positron Lymphography will be defined in terms of sensitivity and will consist of pathology review of labelled, excised specimens compared with lymph node imaging data acquired preoperatively.
1 secondary outcome
to evaluate several standard uptake value (SUV) (18F-FDG avidity)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Jennifer Mueller, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-Fluorodeoxyglucose (18F-FDG), PET/CT imaging and PET/MRI imaging in people with Cervical Cancer and Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
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 17 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
diagnostic accuracy of Positron Lymphography (time frame: 2 years). 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 30 Dec 2025.