Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer

Cervical Cancer Clinical Trial

Official title:

Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02285192
• Other study ID #: 14-222
• Status: Active, not recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Uterine Cervical Neoplasms

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

External Links

•   Memorial Sloan Kettering Cancer Center