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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978874
First Posted: September 17, 2009
Last Update Posted: October 20, 2009
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. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 phase I 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 Intervention Phase
Cervical Cancer Radiation: fludeoxyglucose F 18 Radiation: fluorine F 18 EF5 Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: [F18]EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Carcinoma of the Cervix

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • PET imaging of tumor hypoxia, defined by the maximum standard uptake value and by the tumor to muscle ratio
  • Toxicity as assessed by NCI CTCAE v3.0

Secondary Outcome Measures:
  • Relationship between fluorine F 18 EF5 uptake and disease-free survival and overall survival

Estimated Enrollment: 20
Study Start Date: May 2008
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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): NCT00978874


Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers    800-474-9892      
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
OverallOfficial: Michael Mehler Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Stephen Michael Hahn, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00978874     History of Changes
Other Study ID Numbers: CDR0000654177
UPCC-807592
First Submitted: September 16, 2009
First Posted: September 17, 2009
Last Update Posted: October 20, 2009
Last Verified: September 2009

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Fluorodeoxyglucose F18
Fluorides
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs