IVIM Scans for Predicting Metastasis in Sarcoma

Overseen By David Shultz, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Disqualifiers: Mri contraindication

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

145 Participants Needed

Trial Summary

What is the purpose of this trial?

The hypoxia \> metastasis axis suggests that a DWI-based biomarker of hypoxia incorporating IVIM may be able to predict metastasis in STS patients, ultimately enabling stratification for personalized treatments at the time of diagnostic (MR) imaging, without adding an excessive burden to the patient or clinical workflow (typical DWI/IVIM sequences can be acquired acquired in approximately 5 minutes).

Eligibility Criteria

This trial is for adults over 18 with Grade 2 or 3 soft tissue sarcoma larger than 5 cm who are recommended to have radiotherapy before surgery. Participants must understand and sign a consent form. Those with conditions that make MRI scans unsafe cannot join.

Inclusion Criteria

My sarcoma team recommends radiation before surgery.

Ability to understand and the willingness to sign a written informed consent document

My soft tissue sarcoma is larger than 5 cm and is classified as grade 2 or 3.

Exclusion Criteria

Contraindication to MRI scan as per current institutional guidelines

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Biomarker Assessment

Participants undergo MRI and PET imaging to assess hypoxia and collect plasma samples for biomarker analysis

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for distant metastasis-free survival and correlation of biomarkers over time

3 years

Treatment Details

Trial Overview The study is testing if a type of MRI scan called IVIM can predict the spread of sarcoma by detecting low oxygen levels in tumors, potentially guiding personalized treatment without adding much time to standard diagnostic procedures.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+