Recruiting
Phase 2

Radiomic Images

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT05301283

Conditions

High Grade Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intensity Modulated Radiation Therapy (IMRT)

MRI

Study Details

Brief 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.

Conditions

High Grade Sarcoma

Study ID

NCT05301283

Start date

May 18, 2022

Status verified date

Dec, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Considerations (as outlined in protocol) throughout study duration.
  • Pathologically (histologically or cytologically) proven diagnosis of high-grade (grade 2 or 3) Soft Tissue Sarcoma (STS) of the deep trunk and/or extremity. Clinical evidence should be documented, and may consist of pathology or imaging, and should be sufficient to estimate the size of the primary (for T stage)
  • Primary site deemed resectable prior to the start of trial
  • American Joint Committee on Cancer (AJCC) 8th edition staging T1-4 N0 M0, no evidence of distant metastases
  • Patients must have clinically or radiographically evident measurable disease at the primary site.
  • Pre-Radiation Therapy (RT) MRI within 4 weeks of the start of RT.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 3.
  • Deemed a surgical candidate
  • Participant agrees to blood and plasma preservation for future analysis.

Exclusion Criteria:

  • Contraindications to an MRI
  • Positive urine pregnancy test
  • Gross total excision of primary STS, including an unplanned excision
  • Superficial sarcoma located primarily in the subcutaneous or cutaneous tissue
  • Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields.
  • Participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial.

Study Design

Enrollment

43 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Participants will receive pretreatment diagnostic MRIs to generate MRI habitats (images of tumor regions/subregions in different sequences). These images will identify radioresistant cells within the tumor to allow for more precise and higher doses of radiation to the resistant cells.

Participants will then be treated with neoadjuvant external beam radiation by using the intensity modulated radiation (IMRT) technique, with dose painting (simultaneous integrated boost/SIB) to 70 Gray Units (Gy), 60 Gy, and 50 Gy in 25 fractions for habitats 1, 2, and 3, respectively.

Interventions

Intensity 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.

MRI

Participants will receive pretreatment diagnostic MRIs to generate MRI habitats. These images will identify radioresistant cells within tumor.

Primary outcome measure

  • Rate of Favorable Pathologic Response (FPR) [ Time Frame: Week 10 ]

Central Contacts and Locations

Central contacts

Inaya Lemus

813-745-4233Inaya.Lemus@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Arash O Naghavi, MD, MS

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2025-12-04.