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Completed

NCT Number: 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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorodopa F 18

Drug

Given IV

Other names: (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

Procedure

Undergo PET/MRI

Other names: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Positron Emission Tomography

Procedure

Undergo PET/MRI

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

radiation therapy

Radiation

Receive standard of care radiation therapy

Other names: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Surgical Procedure

Procedure

Undergo standard of care surgery

Other names: Operation, Surgery, Surgery Type, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Primary outcomes

  1. Fluorodopa F 18 (18F-DOPA) positron emission tomography (PET)

    Time frame: Post-radiation therapy (RT), up to 28 days

    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.

  2. Change in 18F-DOPA PET activity

    Time frame: Pre- to post-RT, up to 28 days

    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.

Other outcomes

  1. Pathologic response

    Time frame: Through study completion, an average of 1 year

    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%.

  2. Imaging Endpoint Standardized uptake value (SUV) mean

    Time frame: Up to 3 years

    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.

  3. Imaging Endpoint SUV maximum

    Time frame: Up to 3 years

    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.

  4. Imaging Endpoint Tumor-to-normal SUV

    Time frame: Up to 3 years

    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.

  5. Imaging Endpoint Total metabolic tumor volume

    Time frame: Up to 3 years

    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.

  6. Imaging Endpoint Total tumor glycolysis

    Time frame: Up to 3 years

    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.

  7. Imaging Endpoint Tumor histogram characteristics

    Time frame: Up to 3 years

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2022
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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