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
3 other identifiers
observational
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2022
CompletedFirst Posted
Study publicly available on registry
September 29, 2022
CompletedStudy Start
First participant enrolled
November 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2024
CompletedJuly 10, 2025
July 1, 2025
1.7 years
September 19, 2022
July 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Fluorodopa F 18 (18F-DOPA) positron emission tomography (PET)
Correlated with pathologic response. The correlation between imaging measures and pathologic response will be evaluated using a logistic regression model for each one of the four imaging modalities separately. For each subject, 12-18 measures will be taken, and therefore, an exchangeable correlation structure will be used to model the correlation among the measures from the same patient. Giving the exploratory nature of the study, will not adjust for the multiple comparisons. Pathologic responses and imaging measurements will be summarized using point estimates, and 95% confidence interval as well, for each of the four imaging modalities.
Post-radiation therapy (RT), up to 28 days
Change in 18F-DOPA PET activity
Pre-radiation therapy and post-radiation therapy 18F-DOPA PET activity will be correlated with pathologic response. The correlation between imaging measures and pathologic response will be evaluated using a logistic regression model for each one of the four imaging modalities separately. For each subject, 12-18 measures will be taken, and therefore, an exchangeable correlation structure will be used to model the correlation among the measures from the same patient. Giving the exploratory nature of the study, will not adjust for the multiple comparisons. Pathologic responses and imaging measurements will be summarized using point estimates, and 95% confidence interval as well, for each of the four imaging modalities.
Pre- to post-RT, up to 28 days
Other Outcomes (7)
Pathologic response
Through study completion, an average of 1 year
Imaging Endpoint Standardized uptake value (SUV) mean
Up to 3 years
Imaging Endpoint SUV maximum
Up to 3 years
- +4 more other outcomes
Study Arms (1)
Observational (18F-DOPA PET/MRI)
Patients receive 18F-DOPA IV and undergo PET/MRI over 60 minutes before standard of care radiotherapy and/or before standard of care surgery.
Interventions
Given IV
Undergo PET/MRI
Undergo PET/MRI
Receive standard of care radiation therapy
Undergo standard of care surgery
Eligibility Criteria
Patients planning to receive surgery for high-grade soft tissue sarcoma.
You may qualify if:
- 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
You may not qualify if:
- F-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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deanna Hasenauer, Ph.D.
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2022
First Posted
September 29, 2022
Study Start
November 10, 2022
Primary Completion
July 9, 2024
Study Completion
July 9, 2024
Last Updated
July 10, 2025
Record last verified: 2025-07