145 Participants Needed

IVIM Scans for Predicting Metastasis in Sarcoma

DS
Overseen ByDavid Shultz, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to predict whether soft tissue sarcoma (STS) will spread. Researchers use a special MRI scan technique called IVIM (Intravoxel Incoherent Motion) to detect signs of low oxygen levels (hypoxia) in the tumor, which might indicate potential cancer spread. The goal is to help doctors personalize treatment plans without significantly increasing the time or effort of the usual MRI process. Suitable participants for this trial have a grade 2 or 3 soft tissue sarcoma larger than 5 cm. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to advancements in personalized cancer care.

What prior data suggests that this IVIM scan technique is safe for predicting metastasis in sarcoma patients?

Research has shown that diffusion-weighted imaging (DWI) and intravoxel incoherent motion (IVIM) scans are generally safe for patients. Unlike some other imaging methods, these MRI scans do not use radiation, which can be a concern.

DWI/IVIM technology has been widely used in medical settings and is well-tolerated by patients. No significant reports have linked negative effects directly to these scans. They are similar to other MRIs, which are known for their safety.

This trial is in Phase 2, indicating that earlier studies have already tested the safety of these scans. In Phase 2, researchers focus more on the effectiveness of the scans while still monitoring safety. This suggests a good level of confidence in the safety of the scans.

Overall, DWI/IVIM scans are considered a safe option for patients, providing important information without causing discomfort or harm.

Why are researchers excited about this trial?

Researchers are excited about using IVIM (Intravoxel Incoherent Motion) scans for predicting metastasis in sarcoma because this technique offers a non-invasive way to assess how the cancer might spread. Unlike traditional imaging methods, which often require invasive procedures or might not capture the full picture of potential metastasis, IVIM scans provide detailed data on tissue characteristics and blood flow. This approach could lead to earlier and more accurate predictions of metastasis, helping doctors tailor treatment plans more effectively for patients. By improving our ability to foresee cancer spread, IVIM scans could significantly enhance patient outcomes and management strategies.

What evidence suggests that this IVIM scan is effective for predicting metastasis in sarcoma?

Research has shown that a special type of scan called IVIM might help predict whether sarcoma, a type of cancer, will spread. This scan detects areas in the body with low oxygen levels, known as hypoxia, which may be linked to cancer spreading. IVIM scans can identify these low-oxygen areas without surgery or other invasive methods. Early studies suggest this could help doctors develop better, personalized treatment plans for sarcoma patients. However, more research is needed to confirm its effectiveness.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

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