An Investigational Scan (Fluciclovine F18 PET) for the Diagnosis of Cervical or Endometrial Cancer

Status: Active

Description

This phase IV trial studies how well an investigational scan called fluciclovine F18 positron emission tomography (PET) works in diagnosing cervical or endometrial cancer. Fluciclovine F18 is a type of radioactive diagnostic agent that is injected into the patient and then taken up by tumor cells, which can then be visualized by using PET imaging scans. The purpose of this study is to determine the diagnostic potential of fluciclovine F18 PET when compared to standard of care imaging scans.

Eligibility Criteria

Inclusion Criteria

  • Biopsy-proved cervical cancer or endometrial cancer within three months of study enrollment
  • Standard of care (SOC) FDG PET/CT exam performed within 30 days of study enrollment

Exclusion Criteria

  • No history of cervical cancer or endometrial cancer
  • Primary biopsy > 3 months of study enrollment
  • Systemic therapy or radiation therapy initiated
  • SOC FDG PET/CT exam performed > 30 days of study enrollment
  • Therapeutic procedures (chemotherapy, radiation therapy) have been initiated
  • Pregnancy or lactation
  • Claustrophobia or inability to tolerate the imaging procedure on the PET/MR scanner
  • Individual is not willing to give informed consent

Locations & Contacts

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Contact: Nghi C. Nguyen
Phone: 412-647-0104
Email: nguyennc@upmc.edu
UPMC-Magee Womens Hospital
Status: Active
Contact: Nghi C. Nguyen
Phone: 412-647-0104
Email: nguyennc@upmc.edu
UPMC-Montefiore Hospital
Status: Active
Contact: Nghi C. Nguyen
Phone: 412-647-0104
Email: nguyennc@upmc.edu
UPMC-Presbyterian Hospital
Status: Active
Contact: Nghi C. Nguyen
Phone: 412-647-0104
Email: nguyennc@upmc.edu
UPMC-Shadyside Hospital
Status: Active
Contact: Nghi C. Nguyen
Phone: 412-647-0104
Email: nguyennc@upmc.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To study the pharmacokinetics of fluciclovine F18 (fluciclovine) PET in women with cervical and uterine cancers.

II. To characterize physiologic uptake pattern of the uterus and ovaries when these are not affected by tumor.

III. To identify the optimal time window for the quantitative analysis of fluciclovine primary and pelvic nodal disease.

IV. To correlate the time-activity curve pattern of the primary lesion with histopathologic tumor grading.

V. To compare diagnostic performance of fluciclovine PET and fludeoxyglucose F-18 (FDG) PET.

VI. To compare textural heterogeneity of the primary between fluciclovine PET and FDG PET.

OUTLINE:

Patients receive fluciclovine F18 intravenously (IV) then undergo a PET scan. Approximately 20 minutes later, patients receive gadobenate dimeglumine IV and undergo an MRI scan. The total time for both scans is 60 minutes.

Trial Phase & Type

Trial Phase

Phase IV

Trial Type

Diagnostic

Lead Organization

Lead Organization
University of Pittsburgh Cancer Institute (UPCI)

Principal Investigator
Nghi C. Nguyen

Trial IDs

Primary ID PRO17120310
Secondary IDs NCI-2019-06704
Clinicaltrials.gov ID NCT03423082