NCT Number: NCT02285192
Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
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.
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 1
Primary location
Memorial Sloan Kettering Basking Ridge (Consent only), Basking Ridge, New Jersey, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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
Treatment and study plan
PET/CT imaging
DevicePET/MRI imaging
DevicePrimary outcomes
-
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.
Secondary outcomes
-
to evaluate several standard uptake value (SUV) (18F-FDG avidity)
Time frame: 2 years
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.
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Nov 6, 2014
- Registry last updated
- Dec 30, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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