This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging (MRI) in assessing response to radiation therapy in patients with high grade sarcomas. PET/MRI may help doctors to better judge the extent of cancer, and in the future, may help predict which patients will benefit from radiation therapy treatments.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03076333.
PRIMARY OBJECTIVE:
I. Determine whether there is a significant difference between response groups in PET mean standardized uptake value (SUV) fractional change (baseline to mid-treatment).
SECONDARY OBJECTIVES:
I. Determine whether there is a significant difference between response groups in MRI tumor size fractional change (baseline to mid-treatment).
II. Determine whether there is a significant difference between response groups in PET mean SUV fractional change (baseline to post-treatment).
III. Determine whether there is a significant difference between response groups in MRI tumor size fractional change (baseline to post-treatment).
IV. Assess the correlation in PET mean SUV change and MRI tumor size change from baseline to mid-treatment, in addition to baseline to post-treatment.
EXPLORATORY OBJECTIVES:
I. To assess the utility of combined, simultaneous positron emission tomography (PET mean SUV) and magnetic resonance imaging (MRI tumor size), in early prediction of response to neoadjuvant radiation therapy in the treatment of high-grade sarcomas at mid-treatment and post-treatment.
II. Examine the utility of using maximal SUV in place of mean SUV in prediction of response.
OUTLINE:
Patients undergo a PET/MRI scan during weeks 0, 2, and 8 for a total of 3 scans (pre-treatment, mid-treatment, and post-treatment). Within 60 minutes prior to each scan, patients receive fludeoxyglucose F-18 intravenously (IV). Patients also undergo radiation therapy during weeks 0-4 and surgery during weeks 8-10.
After completion of study treatment, patients are followed for up to 5 years.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorDavid Lalush
