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

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05560009
• Other study ID #: MC220702
• Secondary ID: NCI-2022-0492421
• Status: Recruiting
• Start date: November 10, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Recurrent Soft Tissue Sarcoma
• Resectable Soft Tissue Sarcoma
• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• Fluorodopa F 18
Given IV

Procedure:
• Magnetic Resonance Imaging
Undergo PET/MRI
• Positron Emission Tomography
Undergo PET/MRI

Radiation:
• Radiation Therapy
Receive standard of care radiation therapy

Procedure:
• Surgical Procedure
Undergo standard of care surgery

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pathologic response	Pathologic evaluation of resected specimens by an expert pathologist will be the gold standard for tumor diagnosis and treatment response assessment in this study. Following definitive surgery, the tumor should be examined to determine pathologic response. Since the effect of the preoperative RT may not be uniform throughout the tumor, adequate sampling is required to grade the pathologic response accurately. Tumor's pathologic response will be performed utilizing the grading system below as a guideline: grade I is defined as the percentage of necrosis less than 50%, grade II is defined as the 50%-89% necrosis in the sample, grade III is defined as 90% - 99% necrosis and grade IV is defined as 100% necrosis. The pathological endpoint is defined as the indicator of whether the percentage of necrosis is > 90%.	Through study completion, an average of 1 year
Other	Imaging Endpoint Standardized uptake value (SUV) mean	Imaging endpoints include SUV uptake value mean characteristic. Five patients will be enrolled before RT for additional PET scan for comparison of pre-RT and post-RT SUV metrics, correlated with pathology after surgery, for evaluation of 18F-DOPA PET as a marker for response assessment.	Up to 3 years
Other	Imaging Endpoint SUV maximum	Imaging endpoints include SUV maximum characteristic. Five patients will be enrolled before RT for additional PET scan for comparison of pre-RT and post-RT SUV metrics, correlated with pathology after surgery, for evaluation of 18F-DOPA PET as a marker for response assessment.	Up to 3 years
Other	Imaging Endpoint Tumor-to-normal SUV	Imaging endpoints include tumor to normal SUV characteristic. Five patients will be enrolled before RT for additional PET scan for comparison of pre-RT and post-RT SUV metrics, correlated with pathology after surgery, for evaluation of 18F-DOPA PET as a marker for response assessment.	Up to 3 years
Other	Imaging Endpoint Total metabolic tumor volume	Imaging endpoints include total metabolic tumor volume characteristic. Five patients will be enrolled before RT for additional PET scan for comparison of pre-RT and post-RT SUV metrics, correlated with pathology after surgery, for evaluation of 18F-DOPA PET as a marker for response assessment.	Up to 3 years
Other	Imaging Endpoint Total tumor glycolysis	Imaging endpoints include total tumor glycolysis characteristic. Five patients will be enrolled before RT for additional PET scan for comparison of pre-RT and post-RT SUV metrics, correlated with pathology after surgery, for evaluation of 18F-DOPA PET as a marker for response assessment.	Up to 3 years
Other	Imaging Endpoint Tumor histogram characteristics	Imaging endpoints include tumor histogram characteristic. Five patients will be enrolled before RT for additional PET scan for comparison of pre-RT and post-RT SUV metrics, correlated with pathology after surgery, for evaluation of 18F-DOPA PET as a marker for response assessment.	Up to 3 years
Primary	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.
Primary	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.

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