18F-DOPA PET in Sarcoma Patients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 21-005244
NCT ID: NCT05560009
Sponsor Protocol Number: MC220702
About this study
The purpose of this study is to identify early response biomarkers from biological or functional imaging to better align with clinical trial endpoints and minimize sarcoma patient toxicities.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- PRE-ELIGIBILITY - INCLUSION CRITERIA:
- Age >= 18 years
- Histological confirmation of newly diagnosed high-grade soft tissue sarcoma, or
recurrent high-grade 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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/12/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator Deanna Pafundi, Ph.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available