Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-31 @ 11:19 AM
Study NCT ID:
NCT05950594
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2023-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IVIM & OLINK in Sarcoma
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Prospective Study of Image and Blood-derived Biomarkers to Predict Metastasis in Soft-tissue Sarcomas
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: