Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma
H. Lee Moffitt Cancer Center and Research Institute
Summary
The purpose of the study is to utilize radiomic images to precisely locate areas of tumor that can be treated with dose escalation radiation therapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * For women of childbearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 52 weeks after the end of radiation. * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 52 weeks after radiation. * Agreement to adhere to Lifestyle Cons…
Interventions
- RadiationIntensity Modulated Radiation Therapy (IMRT)
Participants will be treated with intensity modulated radiation therapy (IMRT) with photons, which is FDA (U.S. Food and Drug Administration) approved radiation delivery system.
- Diagnostic TestMRI
Participants will receive pretreatment diagnostic MRIs to generate MRI habitats. These images will identify radioresistant cells within tumor.
Location
- Moffitt Cancer CenterTampa, Florida