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

NCT00978874 | Terminated Results

• 1 other identifier: UPCC 03808
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  7 years

Study Arms (1)

All subjects

EXPERIMENTAL

Radiation: fludeoxyglucose F 18; Radiation: fluorine F 18 EF5

Interventions

fludeoxyglucose F 18 RADIATION

All subjects

fluorine F 18 EF5 RADIATION

All subjects

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Results Point of Contact

• Title: Lilie Lin, MD
• Organization: University of Pennsylvania

lin@xrt.upenn.edu

215-662-6515

Study Officials

• Lilie Lin, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: May 1, 2008
• Primary Completion: September 4, 2013
• Study Completion: September 4, 2013
• Last Updated: June 25, 2021
• Results First Posted: June 25, 2021

Record last verified: 2021-06

Locations

US (1)