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NCT Number: NCT05950594

IVIM & OLINK in Sarcoma

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).

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network

Toronto, Ontario, L4W4C2, Canada

Location status: Recruiting

Location contact

David Shultz, MD

CONTACT

[email protected]

416 946 4501 ext. 6899

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Radiotherapy

Radiation

Standard of care pre-operative radiotherapy

SURGERY

Other

Standard of care definitive surgery

Primary outcomes

  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 outcomes

  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.

  2. Transcriptomic and proteomic expression profiles in circulating immune cells

    Time frame: 3 years

    Transcriptomic expression (measured using RNA sequencing and reported as normalized read counts) and proteomic expression (measured using OLINK proximity-extension assays and reported as NPX units) will be characterized in circulating immune and tumor cells collected before radiotherapy and correlated with distant metastasis-free survival, overall survival, and progression-free survival.

  3. Distant-metastasis free survival

    Time frame: 3 years

  4. Overall survival

    Time frame: 3 years

  5. Progression-free survival

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

David Shultz, MD

CONTACT

[email protected]

416-946-4501 ext. 2121

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Prospective Study of Image and Blood-derived Biomarkers to Predict Metastasis in Soft-tissue Sarcomas

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2023
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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