FAZA-PET/MRI Imaging for Sarcoma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Health Network, Toronto

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

Stay on Your Current Meds

No Placebo Group

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.

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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.

Trial 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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University Health Network Toronto, Canada

Who Is Running the Clinical Trial?

University Health Network, Toronto Lead Sponsor

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] To assess the feasibility of positron emission tomography/magnetic resonance imaging (PET/MR) with 18F-fluordeoxyglucose (FDG) for initial staging of sarcoma.

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

PET for sarcomas other than gastrointestinal stromal tumors. [2016] Positron emission tomography (PET) is increasingly used to diagnose, grade, and stage different types of tumors and to assess tumor response to therapy. Metabolic data acquired by fluorine-18-fluorodeoxyglucose (18FDG)-PET may facilitate accurate grading of sarcomas and have prognostic value when combined with other grading methods and various clinical/radiological features. In addition, 18FDG-PET is currently being evaluated in several cancer types for its utility in biopsy guidance. Whole-body 18FDG-PET also appears to be superior to other imaging modalities in detecting bone metastases in certain sarcoma patients. New PET tracers currently being investigated include 18F-fluorothymidine (18F-FLT) and 18F-misonidazole. 18F-FLT can help to determine tumor growth, rather than tumor shrinkage, which could be used to evaluate treatment response in sarcomas. PET imaging offers invaluable information to help maximize the clinical benefit of patients with sarcoma. This article reviews the use of PET in sarcoma management and its potential applications in the near future.

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

Novel FAP ligands enable improved imaging contrast in sarcoma patients due to FAPI-PET/CT. [2022] Label="PURPOSE">A high expression of fibroblast activation protein (FAP) was observed in multiple sarcomas, indicating an enormous potential for PET/CT using 68Ga-radiolabeled inhibitors of FAP (FAPI). Therefore, this retrospective study aimed to evaluate the role of the novel hybrid imaging probe for sarcomas as a first clinical evaluation.

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] [18F]FAZA is a PET biomarker with great potential for imaging tumor hypoxia. Aim of our study was to compare [18F]FAZA uptake in mice with subcutaneous exogenous CT26 colon carcinomas and endogenous polyoma middle-T (PyV-mT) mammary carcinomas and to analyze the influence of different breathing protocols in CT26 colon carcinomas as well as the reversibility or irreversibility of [18F]FAZA uptake.

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

Fibroblast Activation Protein Inhibitor (FAPI)-PET Imaging in Sarcoma. [2023] Advances in histopathologic and molecular genetic subtyping of sarcoma will potentially allow identification of novel diagnostic and therapeutic targets for specific subtypes, but a "pan-sarcoma" target is needed. This article provides an overview on expression of one potential candidate, fibroblast activation protein alpha in soft tissue and bone sarcoma, and the resulting application of 68Ga-FAPI as novel imaging probes in these rare tumor entities. Current preclinical and clinical data on 68Ga-FAPI-PET/CT in sarcomas are summarized. 68Ga-FAPI-PET-CT potentially offers important complementary information to be used in diagnostic work-up, assessment of therapy response, and prognostication of soft tissue and bone sarcomas.