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[F18]EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Carcinoma of the Cervix


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

[F18]EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Carcinoma of the Cervix


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

PET imaging of tumor hypoxia, defined by the maximum standard uptake value and by the tumor to muscle ratio

Safety Issue:

No

Principal Investigator

Lilie Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

Unspecified

Study ID:

CDR0000654177

NCT ID:

NCT00978874

Start Date:

May 2008

Completion Date:

Related Keywords:

  • Cervical Cancer
  • 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
  • Uterine Cervical Neoplasms

Name

Location
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283