NCT05950594

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for phase_2

Timeline
18mo left

Started Mar 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Mar 2024Nov 2027

First Submitted

Initial submission to the registry

July 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

March 5, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3.7 years

First QC Date

July 10, 2023

Last Update Submit

March 11, 2026

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Identify image-derived, plasma-derived biomarkers of hypoxia

    Image-derived, plasma-derived biomarkers of hypoxia (such as HIF-1alpha, VEGF, osteopontin) acquired before radiation therapy will be assessed for correlation to distant metastasis-free survival.

    3 years

Secondary Outcomes (5)

  • Hypoxia in plasma

    3 years

  • Transcriptomic and proteomic expression profiles in circulating immune cells

    3 years

  • Distant-metastasis free survival

    3 years

  • Overall survival

    3 years

  • Progression-free survival

    3 years

Interventions

SurgeryOTHER

Standard of care definitive surgery

RadiotherapyRADIATION

Standard of care pre-operative radiotherapy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, L4W4C2, Canada

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

RadiotherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

David Shultz, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 18, 2023

Study Start

March 5, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

CA(1)