Radiographic Evaluation of Tumor Biology During Neoadjuvant Radiotherapy for Sarcoma

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Andrew Frankart
Study ID
NCT07487870
Status
Not Yet Recruiting

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Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
May 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Feasibility measured as the percentage of study-specific MRI scans beyond standard of care which are completed [ Time Frame: Treatment weeks 1, 3, and 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Cincinnati Medical CenterCincinnatiOhio45219
Andrew Frankart
Andrew Frankart, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Cincinnati Medical Center· Cincinnati, OH

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