Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Soft Tissue Sarcoma | Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Resectable Soft Tissue Sarcoma | Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorodopa F 18 | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Surgical Procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Fluorodopa F 18
- Procedure: Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
- Radiation: Radiation Therapy
- Procedure: Surgical Procedure
Primary outcomes (2)
- measure
- Fluorodopa F 18 (18F-DOPA) positron emission tomography (PET)
- timeFrame
- Post-radiation therapy (RT), up to 28 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available