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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to measure oxygen levels in sarcoma tumors using a special PET/MRI scan. It tests a radiotracer called FAZA (18F-FAZA) to help doctors better understand and treat sarcomas. Two groups participate: one receives the scan before chemotherapy or radiation, and the other before surgery, with some receiving an additional substance called pimonidazole. Suitable candidates have certain types of high-risk sarcoma and plan to undergo treatment such as chemotherapy, radiation, or surgery. Researchers will follow up with participants by phone after the scan to check for any side effects. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance sarcoma treatment strategies.

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.

What prior data suggests that the FAZA-PET/MRI imaging technique is safe for measuring hypoxia in sarcoma tissues?

Research has shown that 18F-FAZA, a substance used in PET scans to detect low oxygen levels in tumors, is safe for use. One study found that a typical dose of 18F-FAZA is well-tolerated, similar to other common PET scan substances, and does not cause significant side effects.

For trial participants receiving pimonidazole, which helps identify low oxygen areas in tissues, safety data is also encouraging. Studies have indicated that pimonidazole is safe for both animals and humans, with no major side effects reported.

Overall, both 18F-FAZA and pimonidazole have demonstrated good safety records in past research, making them promising for use in clinical settings. Participants in this trial will be closely monitored to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FAZA-PET/MRI imaging technique for sarcoma because it offers a novel way to visualize tumor hypoxia, which is when a tumor is not getting enough oxygen. This method uses a new imaging agent, 18F-FAZA, and could provide more detailed images of tumor environments compared to traditional imaging methods like CT or standard MRI scans. Additionally, pimonidazole is being explored for its potential to highlight hypoxic areas within tumors, which can help tailor more effective treatment plans. These innovations could lead to more personalized and effective treatments for patients with sarcoma, targeting the tumor's unique characteristics.

What evidence suggests that this FAZA-PET/MRI imaging is effective for measuring hypoxia in sarcoma?

In this trial, participants in Arm A will undergo FAZA PET/MRI scans and radiation therapy before surgery. Research has shown that FAZA, a special substance used in PET scans, effectively identifies low oxygen levels in tumors. This aids in understanding how sarcoma might respond to treatment. Studies have found that FAZA PET/MRI scans can better detect these low oxygen areas, which is crucial for planning effective treatments.

Participants in Arm B will receive pimonidazole before surgery, with the option to complete a FAZA PET/MRI scan. Pimonidazole is another method for detecting low oxygen in cancer tissues. It attaches to low oxygen areas, making it a reliable way to identify these zones in tumors. Evidence indicates that pimonidazole effectively marks low oxygen areas in various cancers, which can help predict how tumors will respond to treatment. Together, these tools enhance understanding and may improve treatment outcomes for sarcoma patients. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03418818

Study Details | NCT03418818 | FAZA PET/MRI Sarcoma The study is being conducted to measure the volume of hypoxic tumor in high-risk STS patients, using FAZA-PET/MRI, before and after neoadjuvant radiotherapy/ ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28567495/

Integrated 18F-FDG PET/MRI compared to MRI alone for ... Our results endorse 18 F-FDG PET/MRI to be an excellent imaging method in the evaluation of recurrent STS after surgical excision, yielding superior tumor ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/62/3/348

Evaluation of 18F-FDG PET and DWI Datasets for Predicting ... Our purpose was to evaluate and compare the clinical utility of simultaneously obtained quantitative 18 F-FDG PET and diffusion-weighted MRI datasets

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-10764

An Investigational Scan (18F-FAZA PET/MRI) for the ... This early phase I trial evaluates how well 18F-FAZA positron emission tomography/magnetic resonance imaging (PET/MRI) scans work in checking oxygen level ...

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1055062/full

Advances in PET and MRI imaging of tumor hypoxia Individual patient data meta-analysis of FMISO and FAZA hypoxia PET scans from head and neck cancer patients undergoing definitive radio-chemotherapy.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28209906/

First Evaluation of PET-Based Human Biodistribution and ... Our dosimetry data showed that a 370-MBq injection of 18F-FAZA is safe for clinical use, similar to other widely used PET ligands. In particular, the effective ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4610963/

Longitudinal tumor hypoxia imaging with [18F]FAZA-PET ... Here, we report the use of FAZA-PET for repeated and longitudinal monitoring of tumor hypoxia changes in a mouse xenograft model of HT-29 ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251255.abstract

Simplified hypoxia PET imaging with [18F]FAZA in tumor ... This study aimed to evaluate the feasibility of intraperitoneal (IP) injection of [ 18 F]FAZA as an alternative for imaging tumor hypoxia in mice.

9. jnm.snmjournals.org jnm.snmjournals.org/content/64/supplement_1/P1142

Exploration of 18FAZA-PET kinetic modelling in patient with ... In this study, we assessed the pharmacokinetics of 18F-FAZA in patients with known CLTI. Our aim was to set a baseline as to determine the optimal method of ...