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

This study is currently recruiting participants.
Verified August 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285192
First Posted: November 6, 2014
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
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.

Condition Intervention Phase
Cervical Cancer Endometrial Cancer Radiation: 18F-Fluorodeoxyglucose (18F-FDG) Device: PET/CT imaging Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Estimated Enrollment: 40
Actual Study Start Date: November 2014
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intracervical 18F-FDG injection during a dynamic PET/CT
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. In every other aspect, patients will receive standard peri- and postoperative care.
Radiation: 18F-Fluorodeoxyglucose (18F-FDG) Device: PET/CT imaging

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285192


Contacts
Contact: Nadeem Abu-Rustum, MD 212-639-7051
Contact: Jan Grimm, MD, PhD 646-888-3095

Locations
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Vittoria Arslan-Carlon, MD    212-639-2680      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Nadeem Abu-Rustum, MD    212-639-7051      
United States, New York
Memorial Sloan Kettering Cancer Center at Commack Recruiting
Commack, New York, United States
Contact: Nadeem Abu-Rustum, PhD    212-639-7051      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Nadeem Abu-Rustum, MD    212-639-7051      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nadeem Abu-Rustum, MD    212-639-7051      
Contact: Jan Grimm, MD, PhD    646-888-3095      
Principal Investigator: Nadeem Abu-Rustum         
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Nadeem Abu-Rustum, MD    212-639-7051      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Nadeem Abu-Rustum, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02285192     History of Changes
Other Study ID Numbers: 14-222
First Submitted: November 4, 2014
First Posted: November 6, 2014
Last Update Posted: September 6, 2017
Last Verified: August 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
18F-FDG Injection
Positron Lymphography
Lymphatic Mapping
sentinel lymph nodes
PET/CT
14-222

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action