Recurrent Soft Tissue SarcomaNCT05560009
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
An observational study of Recurrent Soft Tissue Sarcoma and Resectable Soft Tissue Sarcoma, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Soft Tissue Sarcoma, Resectable Soft Tissue Sarcoma, Soft Tissue Sarcoma
- What is being tested?
- Fluorodopa F 18, Magnetic Resonance Imaging and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 9 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients planning to receive surgery for high-grade soft tissue sarcoma.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: Utility of 18F-DOPA PET/MRI Metrics as a Biomarker for Treatment Response Assessment in Sarcoma Patients: A Pilot Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine the correlation between 18F-DOPA PET/MRI quantitative metrics after neoadjuvant treatment (pre-surgery) with percent tumor necrosis.
SECONDARY OBJECTIVE:
- 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.
- Being tested
- Fluorodopa F 18, Magnetic Resonance Imaging, Positron Emission Tomography, Radiation Therapy, Surgical Procedure
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorodopa F 18Drug
Also called (18F)FDOPA, 18F-DOPA, 18F-FDOPA, 3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging
Undergo PET/MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/MRI
Radiation TherapyRadiation
Also called Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated
Receive standard of care radiation therapy
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgical
Undergo standard of care surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fluorodopa F 18; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Radiation: Radiation Therapy; Procedure: Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-radiation therapy (RT), up to 28 days
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.
Measured: Pre- to post-RT, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start10 Nov 2022
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deanna Hasenauer, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560009
- Sponsor's protocol ID
- MC220702
- Other IDs
- NCI-2022-04924, 21-005244
- Status last verified
- Jul 2025
- First submitted
- 19 Sep 2022
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of 18F-DOPA PET/MRI Metrics as a Biomarker for Treatment Response Assessment in Sarcoma Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT05560009
- Acronym / sponsor ID
- MC220702
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the correlation between 18F-DOPA PET/MRI quantitative metrics after neoadjuvant treatment (pre-surgery) with percent tumor necrosis.
SECONDARY OBJECTIVE:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (18F-DOPA PET/MRI) | – | Drug: Fluorodopa F 18, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Radiation: Radiation Therapy, Procedure: Surgical ProcedurePatients receive 18F-DOPA IV and undergo PET/MRI over 60 minutes before standard of care radiotherapy and/or before standard of care surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planning to receive surgery for high-grade soft tissue sarcoma.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorodopa F 18Also: (18F)FDOPA, 18F-DOPA, 18F-FDOPA, 3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanineGiven IV | Drug | Observational (18F-DOPA PET/MRI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR ImagingUndergo PET/MRI | Procedure or surgery | Observational (18F-DOPA PET/MRI) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/MRI | Procedure or surgery | Observational (18F-DOPA PET/MRI) |
| Radiation TherapyAlso: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, IrradiatedReceive standard of care radiation therapy | Radiation | Observational (18F-DOPA PET/MRI) |
| Surgical ProcedureAlso: Operation, Surgery, Surgery Type, SurgicalUndergo standard of care surgery | Procedure or surgery | Observational (18F-DOPA PET/MRI) |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna Hasenauer, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Soft Tissue Sarcoma and Resectable Soft Tissue Sarcoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorodopa F 18 (18F-DOPA) positron emission tomography (PET) (time frame: Post-radiation therapy (RT), up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.