To hear about similar clinical trials, please enter your email below
Trial Title:
Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
NCT ID:
NCT02285192
Condition:
Cervical Cancer
Endometrial Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Fluorodeoxyglucose F18
Conditions: Keywords:
18F-FDG Injection
Positron Lymphography
Lymphatic Mapping
sentinel lymph nodes
PET/CT
14-222
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
18F-Fluorodeoxyglucose (18F-FDG)
Arm group label:
intracervical 18F-FDG injection during a dynamic PET/CT
Intervention type:
Device
Intervention name:
PET/CT imaging
Arm group label:
intracervical 18F-FDG injection during a dynamic PET/CT
Intervention type:
Device
Intervention name:
PET/MRI imaging
Arm group label:
intracervical 18F-FDG injection during a dynamic PET/CT
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.
Criteria for 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
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Consent only)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Monmouth (Consent only)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Bergen (Consent only)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Commack (Consent only)
Address:
City:
Commack
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Westchester (Consent only)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Nassau (Consent only)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Start date:
November 2014
Completion date:
November 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02285192
http://www.mskcc.org/
