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IVIM & OLINK in Sarcoma

ConditionSoft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Health Network, Toronto

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiotherapy

    Radiation

    Standard of care pre-operative radiotherapy

  • Surgery

    Other intervention

    Standard of care definitive surgery

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
3 years

Secondary outcomes

1

Hypoxia in plasma

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.

Time frame
3 years
2

Transcriptomic and proteomic expression profiles in circulating immune cells

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.

Time frame
3 years
3

Distant-metastasis free survival

Time frame
3 years
4

Overall survival

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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