NCT05560009Completed
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
Source: ClinicalTrials.gov · Last updated 10 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 9 (actual)
- First submitted
- 19 Sept 2022
- Start date
- 10 Nov 2022
- Primary completion date
- 9 Jul 2024
- Lead sponsor
- Mayo Clinic
- Diseases
- Sarcoma
- NCT number
- NCT05560009
What you commit to
- Study type: Observational
- Participants enrolled: 9
- From 10 Nov 2022 to the primary completion date, 9 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.