NCT03613259

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

A Pilot Study Investigating ¹⁸F-FLT-PET as a Marker of Response to Preoperative Radiotherapy in Soft Tissue Sarcoma

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Stage II Adult Soft Tissue Sarcoma
• Stage IIA Adult Soft Tissue Sarcoma
• Stage IIB Adult Soft Tissue Sarcoma
• Stage IIC Adult Soft Tissue Sarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage IV Adult Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Fluorothymidine F-18	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Positron Emission Tomography	Undergo fluorothymidine F-18 PET

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2018-08-03
• Last updated: 2020-06-09

Regulatory

• FDA-regulated drug study