Radiographic Evaluation of Tumor Biology During Neoadjuvant Radiotherapy for Sarcoma

This is a single arm study in which patients will undergo MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5) while receiving SOC RT for their soft tissue sarcoma.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcoma
• Intervention / Treatment: Diagnostic test: MRI

Detailed Description

The purpose of this research is to determine if additional imaging during radiotherapy allows for better understanding of tumor's response to radiation and better treatment planning. Modern cancer treatment has used imaging to tailor individual patient treatment and to monitor responses to therapy. Typically, assessments of tumor response to radiation are conducted by repeat imaging after completing therapy. It is known that radiation can change aspects of the tumor which impact response to therapy. These changes can potentially be seen in imaging of the tumor. The researchers in this study believe that additional imaging during treatment will allow for more personalized and better treatment for sarcoma.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: UCCC Clinical Trials Office; Phone Number: 513-584-7698; Email: cancer@uchealth.com
• Study Contact Backup: Name: Andrew Frankart, MD

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
      • Contact: Andrew Frankart
      • Principal Investigator: Andrew Frankart, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed history of soft tissue sarcoma.
2. Plan to receive neoadjuvant radiation to a dose of 50 Gy in 25 fractions followed by surgical resection per Investigator.
3. Age ≥18 years.
4. ECOG performance status ≤2.

Exclusion Criteria:

1. Patients with Ewing's sarcoma and rhabdomyosarcoma.
2. Unable or unwilling to receive gadolinium-based contrast.
3. Patients who are unable or unwilling to undergo MRI studies.
4. Patients who may be unlikely or unable to be able to complete 3 additional MRI studies during the course of their 5-week radiation plan in the opinion of the PI.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5); Patients will undergo RT therapy per SOC and will receive 3 additional MRI studies at the end of RT weeks 1, 3, and 5. Participants will complete their SOC RT and SOC post-radiation MRI imaging. They will then undergo SOC surgical resection at which time a single research specific tissue collection from discarded tissue not required for clinical pathology will be obtained. Patient participation will be completed after the completion of the surgical resection with no additional follow-up or data collection on survival or disease status as the focus of this feasibility study is on tumor changes during treatment. No other differences from a typical treatment course are expected and no additional anti-cancer therapies will be added as a result of the imaging study results.

Diagnostic test: MRI; Patients will undergo RT therapy per SOC and will receive 3 additional MRI studies at the end of RT weeks 1, 3, and 5 with an allowable window of +/- 3 days to account for delays in radiation or unforeseeable circumstances which prevent completion of MRI such as illness or weather.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility measured as the percentage of study-specific MRI scans beyond standard of care which are completed	1. To evaluate the feasibility of completing serial MRI studies during a course of radiation. a. Feasibility will be measured as the percentage of study-specific MRI scans beyond standard of care which are completed at the end of the study with greater than or equal to a 66% completion rate overall (not per patient) being considered feasible.	Treatment weeks 1, 3, and 5

Collaborators and Investigators

• Sponsor: Andrew Frankart

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma
• Other Study ID Numbers: UCCC-RT-25-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No