Brief Title
Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
Official Title
Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
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 which lymph nodes in the pelvis (the area near your uterus and cervix) contain
cancer.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
diagnostic accuracy of Positron Lymphography
Secondary Outcome
to evaluate several standard uptake value (SUV) (18F-FDG avidity)
Condition
Cervical Cancer
Intervention
18F-Fluorodeoxyglucose (18F-FDG)
Study Arms / Comparison Groups
intracervical 18F-FDG injection during a dynamic PET/CT
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
50
Start Date
November 2014
Completion Date
November 2022
Primary Completion Date
November 2022
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jennifer Mueller, MD, 212-639-8229, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02285192
Organization ID
14-222
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Study Sponsor
Jennifer Mueller, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
November 2020