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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Recurrent Soft Tissue Sarcoma, Resectable Soft Tissue Sarcoma, Soft Tissue Sarcoma

Intervention / Treatment
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* Drug: Fluorodopa F 18
* Procedure: Magnetic Resonance Imaging
* Procedure: Positron Emission Tomography
* Radiation: Radiation Therapy
* Procedure: Surgical Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PRE-ELIGIBILITY - INCLUSION CRITERIA: Age >= 18 years Histological confirmation of newly diagnosed high-grade soft tissue sarcoma, or recurrent high-grade 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (18F-DOPA PET/MRI)<br>Patients receive 18F-DOPA IV and undergo PET/MRI over 60 minutes before standard of care radiotherapy and/or before standard of care surgery. | Drug: Fluorodopa F 18<br>* Given IV<br>* Other names: L-6-(18F)Fluoro-DOPA;Procedure: Magnetic Resonance Imaging<br>* Undergo PET/MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Positron Emission Tomography<br>* Undergo PET/MRI<br>* Other names: proton magnetic resonance spectroscopic imaging;Radiation: Radiation Therapy<br>* Receive standard of care radiation therapy<br>* Other names: Therapy, Radiation;Procedure: Surgical Procedure<br>* Undergo standard of care surgery<br>* Other names: Type of Surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |