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NCT05560009 | Recruiting | Recurrent Soft Tissue Sarcoma


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
Sponsor:

Mayo Clinic

Brief 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.

Condition or disease

Recurrent Soft Tissue Sarcoma

Resectable Soft Tissue Sarcoma

Soft Tissue Sarcoma

Intervention/treatment

Fluorodopa F 18

Magnetic Resonance Imaging

Positron Emission Tomography

Radiation Therapy

Surgical Procedure

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.

Study Type : Observational
Estimated Enrollment : 10 participants
Official Title: Utility of 18F-DOPA PET/MRI Metrics as a Biomarker for Treatment Response Assessment in Sarcoma Patients: A Pilot Study
Actual Study Start Date : November 10, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

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

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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

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Locations


Recruiting

United States, Florida

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980

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