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

PRIMARY OBJECTIVES:

I. To determine fluorothymidine F-18 (¹⁸F-FLT) uptake parameters before and after
radiotherapy.

SECONDARY OBJECTIVES:

I. To correlate ¹⁸F-FLT uptake post-radiotherapy scan with pathologic response. II. To
correlate levels the mitotic index in surgical specimens with the ¹⁸F-FLT uptake in
post-radiation scans.

III. To correlate ¹⁸F-FLT uptake both pre- and post-radiotherapy with magnetic resonance
imaging (MRI) enhancement both within and around the tumor.

TERTIARY OBJECTIVES:

I. To compare ¹⁸F-FLT uptake and fludeoxyglucose F-18 (FDG) uptake when FDG-PET-computed
tomography (CT) is available, pre-radiation, post-radiation, or both.

II. To compare ¹⁸F-FLT uptake in post-radiation scans with local recurrences looking for
spatial correlation.

OUTLINE:

Patients receive fluorothymidine F-18 intravenously (IV) over 1 minute and undergo PET scan
over 60 minutes 21 or less days prior to standard of care radiation therapy and 14 or less
days prior to the standard of care surgery.

After completion of study, patients are followed up for 2 years.

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)