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IVIM & OLINK in Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05950594
Recruitment Status : Not yet recruiting
First Posted : July 18, 2023
Last Update Posted : October 27, 2023
Information provided by (Responsible Party):
University Health Network, Toronto

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).

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Radiation: Radiotherapy Other: Surgery Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Study of Image and Blood-derived Biomarkers to Predict Metastasis in Soft-tissue Sarcomas
Estimated Study Start Date : November 30, 2023
Estimated Primary Completion Date : November 30, 2026
Estimated Study Completion Date : November 30, 2026

Resource links provided by the National Library of Medicine

Intervention Details:
  • Radiation: Radiotherapy
    Standard of care pre-operative radiotherapy
  • Other: Surgery
    Standard of care definitive surgery

Primary Outcome Measures :
  1. Identify image-derived, plasma-derived biomarkers of hypoxia [ Time Frame: 3 years ]
    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.

Secondary Outcome Measures :
  1. Hypoxia in plasma [ Time Frame: 3 years ]
    Correlation between the relative concentration of circulating protein biomarkers of hypoxia detected in plasma using proximity-extension assays to hypoxic fraction as calculated by MR imaging and to distant metastasis-free survival.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05950594

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Contact: David Shultz, MD 416-946-4501 ext 2121

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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, L4W4C2
Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT05950594    
Other Study ID Numbers: 23-5436
First Posted: July 18, 2023    Key Record Dates
Last Update Posted: October 27, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type