[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers

• Status: Completed
• Trial end date: 2017-04-30
• Target enrollment: 0
• Participant gender: All

Summary

[F-18] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone marrow will help maintain blood counts. This would impact chemotherapy administration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John M. Buatti
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)

Criteria

Inclusion Criteria:

• Ability to understand and willingness to sign a written informed consent document.

• Recommended to undergo pelvic irradiation with concurrent chemotherapy.

• At least 18 years of age. Pediatrics would be best served by a protocol designed for their specific needs.

• Karnofsky Performance Status of at least 60% at time of screening.

• Life expectancy of greater than 6 months.

• Subject must have normal organ and marrow function (as defined below) within 30 days of study enrollment:

• leukocytes at least 3,000 / µL

• absolute neutrophil count of at least 1500 / µL

• platelets of at least 100,000 / µL

• creatinine equal to or less than the upper limit of normal

• not pregnant (as applicable)

Exclusion Criteria:

• history of allergic reactions attributed to compounds of similar chemical or biologic composition to FLT

• an oncology research protocol requiring full pelvic radiation (i.e., 4 field box technique)

• uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• subjects taking nucleoside analog medications such as those used as antiretroviral agents.