IVIM & OLINK in Sarcoma

Trial Title: IVIM & OLINK in Sarcoma

NCT ID: NCT05950594

Condition: Soft Tissue Sarcoma

Conditions: Official terms:
Sarcoma

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Radiotherapy
Description: Standard of care pre-operative radiotherapy

Intervention type: Other
Intervention name: Surgery
Description: Standard of care definitive surgery

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).

Detailed description: Tumour hypoxia has been implicated as a major driver in STS metastatic dissemination. Despite this, patients are not routinely assessed for hypoxia, largely due to the cost and difficulty involved. PET hypoxia imaging using Fluorine-18-labelled nitroimidazole-based agents such as fluoroazomycin arabinoside (FAZA) provide non-invasive in vivo quantification of hypoxia [5], including in STS. The expense and unproven clinical value of these agents and the long times between their injection and PET scanning (typically, two hours) has limited the uptake of PET-hypoxia imaging as a routine screening modality. In contrast, magnetic resonance imaging (MRI) is standard for diagnosis of STS and is a routine part of the radiation therapy workflow due to its superior contrast between tumour and surrounding normal tissue. In addition, diffusion-weighted magnetic resonance imaging (DWI) can quantify physiological tumour properties such as cellularity and perfusion that may provide information about tumour biology, including hypoxia. Hypoxia results from the interplay between oxygen demand (oxygen consumption rate) and supply (perfusion). Hypothesizing that oxygen consumption increases with increasing cellularity, Hompland and colleagues demonstrated that a biomarker derived from IVIM measurements could predict hypoxia in prostate, breast, and cervical cancer patients. An ongoing prospective imaging study of hypoxia in STS patients at Princess Margaret is investigating the capacity of FAZA to image hypoxia in STS and develop correlative DWI (IVIM)-based biomarkers of hypoxia on a combined PET/MRI scanner.

Criteria for eligibility:
Criteria:
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 - Recommendation from the sarcoma team that the patient should undergo neo-adjuvant radiotherapy prior to surgical resection Exclusion Criteria: - Contraindication to MRI scan as per current institutional guidelines

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: No

Locations:

Facility:
Name: University Health Network

Address:
City: Toronto
Zip: L4W4C2
Country: Canada

Status: Recruiting

Contact:
Last name: David Shultz, MD

Phone: 416 946 4501

Phone ext: 6899
Email: david.shultz@uhn.ca

Start date: March 5, 2024

Completion date: November 30, 2026

Lead sponsor:
Agency: University Health Network, Toronto
Agency class: Other

Source: University Health Network, Toronto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05950594