Radiographic Evaluation of Tumor Biology During Neoadjuvant Radiotherapy for Sarcoma

NCT07487870 | Not Yet Recruiting DMC

• 1 other identifier: UCCC-RT-25-06
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5)

EXPERIMENTAL

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

Interventions

MRI DIAGNOSTIC_TEST

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.

MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with Ewing's sarcoma and rhabdomyosarcoma.
• Unable or unwilling to receive gadolinium-based contrast.
• Patients who are unable or unwilling to undergo MRI studies.
• 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.

Sponsors & Collaborators

• Andrew Frankart: lead

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

UCCC Clinical Trials Office

CONTACT

513-584-7698; cancer@uchealth.com

Andrew Frankart, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single arm study

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)