MRI for Soft Tissue Sarcoma

Overseen By UCCC Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Andrew Frankart

Disqualifiers: Ewing's sarcoma, Rhabdomyosarcoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am able to care for myself and do light activities.

I have been diagnosed with soft tissue sarcoma by a tissue test.

I am scheduled for radiation before surgery as part of my treatment plan.

Exclusion Criteria

I have Ewing's sarcoma or rhabdomyosarcoma.

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

I cannot or do not want to receive gadolinium contrast.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive standard of care radiotherapy with additional MRI studies at the end of weeks 1, 3, and 5

5 weeks

3 additional MRI visits (end of weeks 1, 3, and 5)

Surgical Resection

Participants undergo surgical resection and a single research-specific tissue collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neoadjuvant Radiotherapy

How Is the Trial Designed?

Group I: MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Andrew Frankart

Lead Sponsor