Fluorothymidine F-18 PET in Diagnosing Patients With Intermediate or High Grade Soft Tissue Sarcoma

• Status: Withdrawn
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot early phase I trial studies how well fluorothymidine F-18 positron emission tomography (PET) works in imaging patients with intermediate or high grade soft tissue sarcoma. Fluorothymidine F-18 PET may provide useful information about the tumor's response to treatment and may give the doctors early results that would better help to plan the post-surgical therapy.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Alovudine; Dideoxynucleosides

Criteria

Inclusion Criteria:

• Participants must have histological evidence of an intermediate or high grade soft tissue sarcoma (STS) of any stage

• Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as >= 1 cm with CT scan or MRI

• Prior resection is allowed if there is measurable gross disease and the subject plans to have neoadjuvant radiotherapy followed by resection

• Eastern Cooperative Oncology Group (ECOG) performance status =< 4, Karnofsky performance status >= 40%

• Creatinine =< 3 x upper limit of normal (ULM)

• Blood urea nitrogen (BUN) =< 3 x ULN

• Participants should be willing and able to have both PET-CT scans

• Participants should be eligible for and plan to undergo neoadjuvant radiation therapy and should be seen by a radiation oncologist prior to beginning the study; radiation at an outside facility will be allowed

• Participants should be eligible for and plan to have resection with a surgeon specializing in STS at Oregon Health and Science University (OHSU) and should be seen by said surgeon prior to beginning the study

• Participants should have a life expectancy that is greater than the study duration

• Participants should be willing to use adequate contraception from the time of the first PET-CT scan to 2 months after radiotherapy finishes; should a woman become pregnant while participating in this study, she should inform her treating physician immediately

• Women with childbearing potential must have a negative pregnancy test before each PET-CT scan

• Participants should have the ability to understand and the willingness to sign a written informed consent document

• Participants must sign a study specific consent form prior to registration

Exclusion Criteria:

• Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or significant inflammation at treatment site or psychiatric illness/social situations that would limit compliance with study requirements or whose lab values do not meet the criteria above are excluded

• Pregnant women are excluded from this study

• Breast feeding women are excluded from this study

• Patients receiving chemotherapy during the course of radiation are excluded

• Patients whose weights exceed the tolerance of the table are excluded; the weight limit at OHSU is 450 pounds (lbs)