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

Mayo Clinic

Status: Completed

Conditions: Soft Tissue Sarcoma; Resectable Soft Tissue Sarcoma; Recurrent Soft Tissue Sarcoma

Treatments: Procedure: Magnetic Resonance Imaging; Radiation: Radiation Therapy; Drug: Fluorodopa F 18; Procedure: Surgical Procedure; Procedure: Positron Emission Tomography

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05560009

NCI-2022-04924 (Registry Identifier)

MC220702

21-005244 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PRE-ELIGIBILITY - INCLUSION CRITERIA:
• Age >= 18 years
• Histological confirmation of newly diagnosed soft tissue sarcoma or recurrent soft tissue sarcoma >= 1-year post-treatment
• Tumors > 1 cm in diameter in largest dimension located midline within the torso or neck, retroperitoneal, or lower extremities
• Operable sarcoma, planning to receive surgery with or without neoadjuvant RT/chemotherapy at Mayo Clinic Florida. Systemic therapy is allowed during radiotherapy
• Provide informed written consent
• Willingness to participate in mandatory imaging studies at Mayo Clinic Florida

Exclusion criteria

• POST-ELIGIBILITY - EXCLUSION CRITERIA:

• 18F-DOPA PET uptake deemed as unacceptable for quantitative assessment

• Unable to undergo an 18F-DOPA PET/MRI scan due to standard MRI restrictions, such as for those with certain implanted devices, those who cannot fit inside the bore, or those with severe claustrophobia

• Any of the following:

  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception

Trial design

9 participants in 1 patient group

Observational (18F-DOPA PET/MRI)

Description:

Patients receive 18F-DOPA IV and undergo PET/MRI over 60 minutes before standard of care radiotherapy and/or before standard of care surgery.

Treatment:

Procedure: Surgical Procedure

Procedure: Positron Emission Tomography

Drug: Fluorodopa F 18

Radiation: Radiation Therapy

Procedure: Magnetic Resonance Imaging