Status:
ACTIVE_NOT_RECRUITING
Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Cervical Cancer
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 whic...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02285192
Start Date
November 1 2014
End Date
November 1 2026
Last Update
December 30 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States