Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
Running, not enrolling · Phase 1
Conditions studied: Cervical Cancer, Endometrial Cancer
In brief
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.
Key facts
- Study ID
- NCT02285192
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 42
- Starts
- 2014-11-01
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2025-12-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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
You may not qualify if…
- 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
- 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
Where it is running
- Memorial Sloan Kettering Basking Ridge (Consent only) — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (Consent only) — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (Consent only) — Montvale, New Jersey, United States
- Memorial Sloan Kettering Commack (Consent only) — Commack, New York, United States
- Memorial Sloan Kettering Westchester (Consent only) — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Memorial Sloan Kettering Nassau (Consent only) — Uniondale, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.