Trial Title:
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
NCT ID:
NCT05560009
Condition:
Recurrent Soft Tissue Sarcoma
Resectable Soft Tissue Sarcoma
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Levodopa
Fluorides
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Fluorodopa F 18
Description:
Given IV
Arm group label:
Observational (18F-DOPA PET/MRI)
Other name:
(18F)FDOPA
Other name:
18F-DOPA
Other name:
18F-FDOPA
Other name:
3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine
Other name:
6-(18F)Fluoro-L-DOPA
Other name:
Fluorine F 18 Fluorodopa
Other name:
Fluorine-18-fluoro-L-DOPA
Other name:
Fluorodopa (18F)
Other name:
FLUORODOPA F-18
Other name:
L-6-(18F)Fluoro-DOPA
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo PET/MRI
Arm group label:
Observational (18F-DOPA PET/MRI)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/MRI
Arm group label:
Observational (18F-DOPA PET/MRI)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
Receive standard of care radiation therapy
Arm group label:
Observational (18F-DOPA PET/MRI)
Other name:
Cancer Radiotherapy
Other name:
ENERGY_TYPE
Other name:
Irradiate
Other name:
Irradiated
Other name:
Irradiation
Other name:
Radiation
Other name:
Radiation Therapy, NOS
Other name:
Radiotherapeutics
Other name:
Radiotherapy
Other name:
RT
Other name:
Therapy, Radiation
Intervention type:
Procedure
Intervention name:
Surgical Procedure
Description:
Undergo standard of care surgery
Arm group label:
Observational (18F-DOPA PET/MRI)
Other name:
Operation
Other name:
Surgery
Other name:
Surgery Type
Other name:
Surgical
Other name:
Surgical Intervention
Other name:
Surgical Interventions
Other name:
Surgical Procedures
Other name:
Type of Surgery
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.
Criteria for eligibility:
Study pop:
Patients planning to receive surgery for high-grade soft tissue sarcoma.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Start date:
November 10, 2022
Completion date:
July 9, 2027
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05560009
https://www.mayo.edu/research/clinical-trials
