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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02285192
Other study ID # 14-222
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date November 2014
Est. completion date November 2025

Study information

Verified date July 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 42
Est. completion date November 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Radiation:
18F-Fluorodeoxyglucose (18F-FDG)

Device:
PET/CT imaging

PET/MRI imaging


Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Consent only) Basking Ridge 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 Monmouth (Consent only) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Consent only) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Consent only) Uniondale New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary diagnostic accuracy of Positron Lymphography 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. 2 years
Secondary to evaluate several standard uptake value (SUV) (18F-FDG avidity) 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. 2 years
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