NCT05560009

An Imaging Agent (Fluorodopa F 18) With Positron Emission Tomography/Magnetic Resonance Imaging for Assessing Treatment Response in Patients With High-Grade Soft Tissue Sarcomas

Utility of 18F-DOPA PET/MRI Metrics as a Biomarker for Treatment Response Assessment in Sarcoma Patients: A Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the use of a new imaging agent called fluorodopa F 18 (18F-DOPA) with positron emission tomography/magnetic resonance imaging (PET/MRI) for assessing treatment response in patients undergoing standard of care radiation therapy and/or surgery for high-grade soft tissue sarcomas that are new or that have come back (recurrent). Though there have been improvements in treatment options for soft tissue sarcomas, there is currently a need for a non-invasive way to determine a patient's potential benefit from receiving one of these treatments. 18F-DOPA with PET/MRI allows a patient's tumor to be visualized and their response to a given treatment assessed.

Detailed description

PRIMARY OBJECTIVE: I. Determine the correlation between 18F-DOPA PET/MRI quantitative metrics after neoadjuvant treatment (pre-surgery) with percent tumor necrosis. SECONDARY OBJECTIVE: I. Compare the changes in 18F-DOPA PET/MRI quantitative metrics between baseline (before radiotherapy \[RT\]) and after RT, but before surgery with percent tumor necrosis. OUTLINE: Patients receive 18F-DOPA intravenously (IV) and undergo PET/MRI over 60 minutes before standard of care radiotherapy and/or before standard of care surgery.

Conditions

• Recurrent Soft Tissue Sarcoma
• Resectable Soft Tissue Sarcoma
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Fluorodopa F 18	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo PET/MRI
PROCEDURE	Positron Emission Tomography	Undergo PET/MRI
RADIATION	Radiation Therapy	Receive standard of care radiation therapy
PROCEDURE	Surgical Procedure	Undergo standard of care surgery

Timeline

• Start date: 2022-11-10
• Primary completion: 2024-07-09
• Completion: 2024-07-09
• First posted: 2022-09-29
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study