Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer.

• Status: Terminated
• Trial end date: 2019-12-18
• Target enrollment: 0
• Participant gender: Female

Summary

18F Fluciclovine is a recently FDA- approved radiopharmaceutical for prostate cancer biochemical recurrence, which is only minimally eliminated by the kidneys and therefore the image interpretation is not affected by nonspecific urine activity in the ureters and bladder, which is advantageous for pelvic imaging. Recent literature suggests that Fluciclovine PET has diagnostic potential for a variety of solid tumors, thus, allowing new opportunities for noninvasive probing of glutamine metabolism and clinical use in patient management. Current literature indicates that amino acid transporters including that of glutamine are upregulated in endometrial and cervical cancer so that Fluciclovine PET may have clinical potentials. The hypothesis is that Fluciclovine PET provides better imaging properties and greater diagnostic confidence and accuracy than FDG PET does in pelvic malignancies.

Given the lack of current clinical data, a pilot study providing a direct comparison of Fluciclovine PET with FDG PET is warranted. The investigators seek to conduct a pilot study with 10 subjects to evaluate the clinical utility of Fluciclovine PET for staging of cervical cancer and endometrial cancer. This research will compare the diagnostic performance of the research Fluciclovine PET/MRI with the standard-of-care FDG PET/CT as an exploratory endpoint.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nghi Nguyen
• Collaborator: Blue Earth Diagnostics

Criteria

Inclusion Criteria:

• Female

• 18 years and older

• 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:

• Female < 18 years old

• 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