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Fluorine F 18 EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fludeoxyglucose F 18
fluorine F 18 EF5
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring recurrent cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of carcinoma of the cervix meeting 1 of the following criteria:

    • Pathologically confirmed, newly diagnosed stage IB-IVA (locally advanced) disease
    • Imaging evidence of recurrent or metastatic disease
  • Measurable disease, defined as ≥ 1 cm on anatomic imaging

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • WBC > 2,000/mm³
  • Platelet count > 90,000/mm³
  • Total bilirubin < 2.0 mg/dL
  • Creatinine < 2.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to Flagyl (metronidazole)
  • No other condition or personal circumstance that, in the judgment of the Investigator, may interfere with the collection of complete, good-quality data

PRIOR CONCURRENT THERAPY:

  • Not specified

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

Outcomes

Primary Outcome Measures

Relationship Between Fluorine F 18 EF5 Uptake and Disease-free Survival and Overall Survival
The study was terminated and no data are available to be reported

Secondary Outcome Measures

Full Information

First Posted
September 16, 2009
Last Updated
June 4, 2021
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00978874
Brief Title
Fluorine F 18 EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Cervical Cancer
Official Title
[F18]EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Carcinoma of the Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
The PI is no longer with our institution
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 4, 2013 (Actual)
Study Completion Date
September 4, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Diagnostic procedures, such as fluorine F 18 EF5 PET/CT imaging, may help find oxygen in tumor cells. It may also help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This trial is studying fluorine F 18 EF5 PET/CT imaging to see how well it works in finding hypoxia in tumor cells of patients with locally advanced or recurrent/metastatic cervical cancer.
Detailed Description
OBJECTIVES: To determine if the presence and heterogeneity of hypoxia can be detected by fluorine F 18 EF5 binding in tumors during PET/CT imaging in patients with newly diagnosed or recurrent carcinoma of the cervix. To determine if fludeoxyglucose F 18 uptake correlates with fluorine F 18 EF5 uptake. To assess the relationship between fluorine F 18 EF5 uptake and disease-free and overall survival. OUTLINE: Patients are stratified according to disease stage (locally advanced vs recurrent or metastatic disease). Patients receive fluorine F 18 EF5 IV followed by PET/CT imaging from the base of skull to upper thigh at baseline and during radiotherapy or chemotherapy (i.e., at 3-4 weeks after the initiation of radiotherapy or after the 4th, 5th, or 6th course of chemotherapy). Patients also undergo fludeoxyglucose F 18 PET/CT imaging within 7 to 10 days of the second fluorine F 18 EF5 scan. After completion of study treatment, patients are followed up at 30 days and then annually thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
recurrent cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Intervention Type
Radiation
Intervention Name(s)
fluorine F 18 EF5
Primary Outcome Measure Information:
Title
Relationship Between Fluorine F 18 EF5 Uptake and Disease-free Survival and Overall Survival
Description
The study was terminated and no data are available to be reported
Time Frame
7 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of carcinoma of the cervix meeting 1 of the following criteria: Pathologically confirmed, newly diagnosed stage IB-IVA (locally advanced) disease Imaging evidence of recurrent or metastatic disease Measurable disease, defined as ≥ 1 cm on anatomic imaging PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% WBC > 2,000/mm³ Platelet count > 90,000/mm³ Total bilirubin < 2.0 mg/dL Creatinine < 2.0 mg/dL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reactions attributed to Flagyl (metronidazole) No other condition or personal circumstance that, in the judgment of the Investigator, may interfere with the collection of complete, good-quality data PRIOR CONCURRENT THERAPY: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilie Lin, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fluorine F 18 EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Cervical Cancer

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