FAZA-PET/MRI Imaging for Sarcoma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Previous radiotherapy, Previous systemic therapy, Active malignancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Varies by treatment

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a dual arm, single centre, investigator initiated study to investigate the use of FAZA-PET in combination with MRI. FAZA is an investigational radiotracer used in PET scans. FAZA PET/MRI will be used to measure hypoxia in sarcoma tissues and will occur for: Arm A: before neo-adjuvant radiation/chemotherapy treatment; Arm B: before surgery (optional). After the FAZA PET/MRI scan, patients will be followed up via telephone, 48 hours after the scan, to see if there are any side effects due to FAZA. Up to 30 patients enrolled in Arm B will receive pimonidazole approximately 16-20 hours before surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

How does FAZA-PET/MRI imaging differ from other sarcoma treatments?

FAZA-PET/MRI imaging is unique because it uses a special PET biomarker called [18F]FAZA to detect tumor hypoxia (low oxygen levels in tumors), which can provide important information about the tumor's environment and potentially guide treatment decisions. This approach is different from traditional imaging methods that may not specifically target hypoxia. ^{1 2 3 4 5}

Eligibility Criteria

Adults with high-risk sarcoma (specific types like leiomyosarcoma or dedifferentiated liposarcoma) who are planning to undergo radiotherapy, chemotherapy, or surgery. Participants must be able to lie down for at least an hour and not be pregnant or breastfeeding. Those with previous cancer treatments or other active cancers cannot join.

Inclusion Criteria

Ability to provide written informed consent to participate in the study

I have a high-risk soft tissue sarcoma in my limbs or a high-risk retroperitoneal sarcoma.

I plan to follow the Sarcoma Site Group's treatment guidelines.

Exclusion Criteria

I have had treatment that affects my whole body.

I have a cancer diagnosis that is not sarcoma.

I have had radiotherapy in the areas where I now need treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo FAZA PET/MRI scan to measure hypoxia in sarcoma tissues

1 day

1 visit (in-person)

Treatment

Participants in Arm A receive neo-adjuvant radiation/chemotherapy; Arm B participants receive pimonidazole before surgery

Varies by treatment

Follow-up

Participants are monitored for side effects via telephone 48 hours after the FAZA PET/MRI scan

48 hours

1 follow-up call

Treatment Details

Interventions

• 18F-FAZA
• Pimonidazole

Trial Overview The trial is testing FAZA-PET combined with MRI to measure oxygen levels in sarcoma tissues before treatment starts. One group will have the scan before radiation/chemotherapy, while another may have it before surgery. Some patients will also receive pimonidazole prior to surgery.

Participant Groups

Group I: Arm B Experimental Treatment 1 Intervention

Participants will receive pimonidazole prior to surgery. Participants in Arm B also have the option to complete a FAZA PET/MRI scan prior to surgery.

Group II: Arm A Experimental Treatment 1 Intervention

Participants will complete FAZA PET/MRI scan and radiation therapy before surgery.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of 29 patients with sarcoma, positron emission tomography/magnetic resonance imaging (PET/MR) using 18F-fluordeoxyglucose (FDG) demonstrated excellent agreement with conventional imaging methods (CT and MR) for initial staging, with a perfect kappa value of 1 for T and M stages.

For N staging, PET/MR was identical to conventional imaging in 28 out of 29 patients, indicating high reliability, and a kappa value of 0.65 suggests good agreement overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDG PET/MR in initial staging of sarcoma: Initial experience and comparison with conventional imaging. Platzek, I., Beuthien-Baumann, B., Schramm, G., et al.[2018]

Positron emission tomography (PET) using 18FDG is effective in diagnosing and grading sarcomas, providing valuable metabolic data that can enhance prognostic accuracy when combined with other clinical features.

New PET tracers like 18F-FLT are being explored for their ability to assess tumor growth, which could improve treatment response evaluation in sarcoma patients, highlighting the evolving role of PET in cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET for sarcomas other than gastrointestinal stromal tumors. Toner, GC., Hicks, RJ.[2016]

In a study involving 15 patients with sarcomas, the use of 68Ga-FAPI-PET/CT demonstrated excellent tumor-to-background ratios, indicating its potential effectiveness in accurately imaging sarcomas.

The highest uptake of the imaging probe was observed in liposarcomas and high-grade tumors, suggesting that 68Ga-FAPI-PET/CT could be particularly useful for identifying more aggressive forms of sarcoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel FAP ligands enable improved imaging contrast in sarcoma patients due to FAPI-PET/CT. Koerber, SA., Finck, R., Dendl, K., et al.[2022]

The study found that [18F]FAZA, a PET biomarker for imaging tumor hypoxia, showed similar uptake in both CT26 colon carcinomas and PyV-mT mammary carcinomas, indicating its effectiveness across different tumor types.

Different breathing protocols affected the uptake of [18F]FAZA, with air breathing leading to higher tumor-to-muscle ratios compared to pure oxygen, suggesting that reduced oxygen supply enhances tracer uptake in tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant impact of different oxygen breathing conditions on noninvasive in vivo tumor-hypoxia imaging using [¹⁸F]-fluoro-azomycinarabino-furanoside ([¹⁸F]FAZA). Maier, FC., Kneilling, M., Reischl, G., et al.[2021]

Advances in understanding sarcoma subtypes may lead to new diagnostic and treatment options, but there is a need for a universal target across all sarcomas.

The use of 68Ga-FAPI-PET/CT imaging shows promise in providing valuable information for diagnosing, assessing treatment responses, and predicting outcomes in soft tissue and bone sarcomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibroblast Activation Protein Inhibitor (FAPI)-PET Imaging in Sarcoma. Kessler, L.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

FDG PET/MR in initial staging of sarcoma: Initial experience and comparison with conventional imaging. [2018]

2. England pubmed.ncbi.nlm.nih.gov

PET for sarcomas other than gastrointestinal stromal tumors. [2016]

3. Germany pubmed.ncbi.nlm.nih.gov

Novel FAP ligands enable improved imaging contrast in sarcoma patients due to FAPI-PET/CT. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Significant impact of different oxygen breathing conditions on noninvasive in vivo tumor-hypoxia imaging using [¹⁸F]-fluoro-azomycinarabino-furanoside ([¹⁸F]FAZA). [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Fibroblast Activation Protein Inhibitor (FAPI)-PET Imaging in Sarcoma. [2023]