Clinical trial NCT05560009: 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
Official title: Utility of 18F-DOPA PET/MRI Metrics as a Biomarker for Treatment Response Assessment in Sarcoma Patients: A Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Recurrent Soft Tissue Sarcoma
Resectable Soft Tissue Sarcoma
Soft Tissue Sarcoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planning to receive surgery for high-grade soft tissue sarcoma.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fluorodopa F 18 (18F-DOPA) positron emission tomography (PET)
timeFrame: Post-radiation therapy (RT), up to 28 days
measure: Change in 18F-DOPA PET activity
timeFrame: Pre- to post-RT, up to 28 days
Secondary outcomes:
Other outcomes:
measure: Pathologic response
timeFrame: Through study completion, an average of 1 year
measure: Imaging Endpoint Standardized uptake value (SUV) mean
timeFrame: Up to 3 years
measure: Imaging Endpoint SUV maximum
timeFrame: Up to 3 years
measure: Imaging Endpoint Tumor-to-normal SUV
timeFrame: Up to 3 years
measure: Imaging Endpoint Total metabolic tumor volume
timeFrame: Up to 3 years
measure: Imaging Endpoint Total tumor glycolysis
timeFrame: Up to 3 years
measure: Imaging Endpoint Tumor histogram characteristics
timeFrame: Up to 3 years
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Deanna H. Pafundi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: