Recruiting
Phase 2

IVIM & OLINK

Sponsor:

University Health Network, Toronto

Code:

NCT05950594

Conditions

Soft Tissue Sarcoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Radiotherapy

Surgery

Study Details

Brief summary:

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).

Conditions

Soft Tissue Sarcoma

Study ID

NCT05950594

Start date

Mar 5, 2024

Status verified date

Mar, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years
  • Ability to understand and the willingness to sign a written informed consent document
  • Grade 2 or 3 soft tissue sarcoma greater than 5 cm in largest dimension

Exclusion Criteria:

  • Contraindication to MRI scan as per current institutional guidelines (for patients requiring MRI)

Study Design

Enrollment

145 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

Radiotherapy

Standard of care pre-operative radiotherapy

Surgery

Standard of care definitive surgery

Primary outcome measure

  • Identify image-derived, plasma-derived biomarkers of hypoxia [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

David Shultz, MD

416-946-4501david.shultz@rmp.uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, L4W4C2

Contacts

David Shultz, MD

416 946 4501david.shultz@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-16.