Soft Tissue SarcomaPhase 2NCT05950594
IVIM & OLINK in Sarcoma
A Phase 2 study testing Radiotherapy and Surgery in people with Soft Tissue Sarcoma, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Radiotherapy and Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 145 participants
- Where
- 1 siteCanada
- Study dates
- 5 Mar 2024to 30 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to MRI scan as per current institutional guidelines (for patients requiring MRI)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, L4W4C2
David Shultz, MD, 416 946 4501 ext. 6899, david.shultz@uhn.ca
About this study
Official title: Prospective Study of Image and Blood-derived Biomarkers to Predict Metastasis in Soft-tissue Sarcomas
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).
Read the 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.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Radiotherapy, Surgery
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Standard of care pre-operative radiotherapy
SurgeryOther
Standard of care definitive surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (5)
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.
Measured: 3 years
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.
Measured: 3 years
Distant-metastasis free survival
Measured: 3 years
Overall survival
Measured: 3 years
Progression-free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start5 Mar 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950594
- Sponsor's protocol ID
- 23-5436
- Status last verified
- Mar 2026
- First submitted
- 10 Jul 2023
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Image and Blood-derived Biomarkers to Predict Metastasis in Soft-tissue Sarcomas
- ClinicalTrials.gov ID
- NCT05950594
- Acronym / sponsor ID
- 23-5436
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindication to MRI scan as per current institutional guidelines (for patients requiring MRI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyStandard of care pre-operative radiotherapy | Radiation | – |
| SurgeryStandard of care definitive surgery | Other | – |
Primary outcome
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.
5 secondary outcomes
Hypoxia in plasma
Time frame: 3 years
Transcriptomic and proteomic expression profiles in circulating immune cells
Time frame: 3 years
Distant-metastasis free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Progression-free survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
Related trials for Soft Tissue Sarcoma
Not yet recruitingPhase 2
Combination of Avutometinib and Defactinib for Treatment of Relapsed, Refractory, Metastatic, or Unresectable Malignant Peripheral Nerve Sheath Tumor
MPNST (Malignant Peripheral Nerve Sheath Tumor)
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
RecruitingPhase 1
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma
RecruitingPhase 2
Trastuzumab Deruxtecan (DS-8201a) for the Treatment of Recurrent or Refractory Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor
Desmoplastic Small Round Cell Tumor, Osteosarcoma
Not yet recruiting
Large Language Model Support for CTEPH Differential Diagnosis
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy and Surgery in people with Soft Tissue Sarcoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Shultz, MD (416-946-4501 ext. 2121, david.shultz@rmp.uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify image-derived, plasma-derived biomarkers of hypoxia (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.