Fluorine F 18 EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Cervical Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: All subjects
|
Radiation: fludeoxyglucose F 18
Radiation: fluorine F 18 EF5
|
Outcome Measures
Primary Outcome Measures
- Relationship Between Fluorine F 18 EF5 Uptake and Disease-free Survival and Overall Survival [7 years]
The study was terminated and no data are available to be reported
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104-4283 |
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Lilie Lin, MD, Abramson Cancer Center of the University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UPCC 03808
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | fludeoxyglucose F 18 fluorine F 18 EF5 |
| Period Title: Overall Study | |
| STARTED | 0 |
| COMPLETED | 0 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | fludeoxyglucose F 18 fluorine F 18 EF5 |
| Overall Participants | 0 |
| Age (years) [] | |
| Sex: Female, Male () [] | |
| Female | |
| Male | |
| Ethnicity (NIH/OMB) () [] | |
| Hispanic or Latino | |
| Not Hispanic or Latino | |
| Unknown or Not Reported | |
| Race (NIH/OMB) () [] | |
| American Indian or Alaska Native | |
| Asian | |
| Native Hawaiian or Other Pacific Islander | |
| Black or African American | |
| White | |
| More than one race | |
| Unknown or Not Reported | |
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The study was terminated and no data are available to be reported |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | fludeoxyglucose F 18 fluorine F 18 EF5 |
| Measure Participants | 0 |
Adverse Events
| Time Frame | All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed | |
|---|---|---|
| Adverse Event Reporting Description | The study was terminated and no data are available to be reported | |
| Arm/Group Title | All Subjects | |
| Arm/Group Description | fludeoxyglucose F 18 fluorine F 18 EF5 | |
All Cause Mortality |
||
| All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Serious Adverse Events |
||
| All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Lilie Lin, MD |
|---|---|
| Organization | University of Pennsylvania |
| Phone | 215-662-6515 |
| lin@xrt.upenn.edu |
- UPCC 03808