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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-10

Study Completion Date

2024-07-09

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.

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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.

Conditions

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Recurrent Soft Tissue Sarcoma Resectable Soft Tissue Sarcoma Soft Tissue Sarcoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Fluorodopa F 18

Intervention Type DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo PET/MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/MRI

Radiation Therapy

Intervention Type RADIATION

Receive standard of care radiation therapy

Surgical Procedure

Intervention Type PROCEDURE

Undergo standard of care surgery

Interventions

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Fluorodopa F 18

Given IV

Intervention Type DRUG

Magnetic Resonance Imaging

Undergo PET/MRI

Intervention Type PROCEDURE

Positron Emission Tomography

Undergo PET/MRI

Intervention Type PROCEDURE

Radiation Therapy

Receive standard of care radiation therapy

Intervention Type RADIATION

Surgical Procedure

Undergo standard of care surgery

Intervention Type PROCEDURE

Other Intervention Names

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(18F)FDOPA 18F-DOPA 18F-FDOPA 3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine 6-(18F)Fluoro-L-DOPA Fluorine F 18 Fluorodopa Fluorine-18-fluoro-L-DOPA Fluorodopa (18F) FLUORODOPA F-18 L-6-(18F)Fluoro-DOPA Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging Cancer Radiotherapy ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation Operation Surgery Surgery Type Surgical Surgical Intervention Surgical Interventions Surgical Procedures Type of Surgery

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No