FAZA PET/MRI Scan for Gastroesophageal Cancer

Overseen By Nirushini Sivasothy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must be taking: Platinum-based chemotherapy

Disqualifiers: Pregnancy, Breastfeeding, MR contraindication, others

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

Compensation: Varies

Number of Visits: 3

Duration: Varies based on chemotherapy regimen

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special imaging method called FAZA PET/MRI for individuals with metastatic gastroesophageal cancer. The goal is to determine if this scan can predict patient responses to standard chemotherapy. The scan uses a "dye" called 18F-Fluoroazomycin Arabinoside (FAZA) to highlight low-oxygen areas in tumors, which can make them more aggressive and difficult to treat. Suitable participants have gastroesophageal cancer, are receiving platinum-based chemotherapy, and do not have allergies to certain contrast agents. The trial will not alter current treatments but aims to improve future treatment options. As an unphased trial, it offers patients the chance to contribute to research that could enhance future cancer treatment strategies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, as the study focuses on imaging and does not change your clinical management.

What prior data suggests that the FAZA PET/MRI scan is safe for patients with gastroesophageal cancer?

Research has shown that 18F-Fluoroazomycin Arabinoside (FAZA), used in PET/MRI scans for gastroesophageal cancer, is generally safe for humans. FAZA primarily serves as a PET tracer, acting like a "dye" to highlight tumor areas with low oxygen, which often correlate with more aggressive cancers.

Previous studies found that using FAZA in imaging is usually safe, with no major safety issues reported. This trial uses FAZA solely for imaging purposes, not as a treatment, which typically involves lower risks.

Although detailed data from this trial phase isn't available yet, FAZA has been used in other research without significant side effects, suggesting it is safe for imaging studies. Participants should discuss any concerns with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FAZA PET/MRI scan for gastroesophageal cancer because it offers a cutting-edge way to visualize tumors by using 18F-Fluoroazomycin Arabinoside (FAZA), which targets low-oxygen areas in cancer cells, unlike standard imaging methods. This technique could provide more accurate assessments of how well the cancer is responding to chemotherapy. By offering a more precise picture of the tumor environment, FAZA PET/MRI could help doctors tailor treatment plans more effectively, potentially improving outcomes for patients.

What evidence suggests that the FAZA PET/MRI scan is effective for gastroesophageal cancer?

Research has shown that a special imaging technique called FAZA PET/MRI can identify areas in tumors with low oxygen levels, known as hypoxia. This is crucial because tumors with low oxygen are often more aggressive and harder to treat. Studies have found that measuring hypoxia with FAZA can predict how well a tumor will respond to treatments like radiation. Specifically, FAZA scans predicted poor response to radiation with high accuracy (92.3%) and reliability (71.4%). In this trial, participants will undergo FAZA PET/MRI scans before and after standard chemotherapy. This approach could help doctors choose better treatment plans for patients with gastroesophageal cancer. ^{3 5 6 7 8}

Who Is on the Research Team?

Patrick Veit-Haibach, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced gastroesophageal cancer who can lie down for at least 30 minutes and have a kidney function test (GFR) above 45 ml/min. It's not suitable for those allergic to contrast agents, pregnant or breastfeeding women, anyone unable to consent, or those with allergies to ethanol.

Inclusion Criteria

Patients with de novo or secondary metastasized gastro-oesophagesal cancer (adenocarcinoma)

Glomerular Filtration rate> 45 ml/min

No allergy to contrast agents

Exclusion Criteria

Contraindication for MR as per current institutional guidelines

Inability to lie supine for at least 30 minutes

Any patient who is pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Imaging

Participants undergo FAZA PET/MRI scan to measure hypoxia before chemotherapy

2 weeks

1 visit (in-person)

Treatment

Participants receive standard of care platinum-based chemotherapy

Varies based on chemotherapy regimen

Post-treatment Imaging

Participants undergo FAZA PET/MRI scan to measure hypoxia after chemotherapy

Immediately after chemotherapy

1 visit (in-person)

Follow-up

Participants are monitored for clinical outcomes and tumor marker ctDNA in blood samples

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 18F-Fluoroazomycin Arabinoside (FAZA)

Trial Overview The study tests if a PET/MRI scan using a special dye called FAZA can predict how well patients respond to standard platinum-based chemotherapy. Patients will get scanned before and after treatment to see if the level of oxygen in their tumors correlates with their response.

How Is the Trial Designed?

Group I: FAZA PET/MRI scan Experimental Treatment 1 Intervention

FAZA PET/MRI scan before and after the standard of care chemotherapy

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

The study identified the reversible two-tissue compartment model with blood volume parameter (2T4k+VB) as the best method for analyzing the kinetics of the PET tracer [(18)F]FAZA in non-small cell lung cancer patients, based on dynamic scans from nine participants.

It was found that using image-derived plasma input functions (IDIF) with venous blood samples can effectively replace traditional arterial blood sampling for analyzing [(18)F]FAZA studies, simplifying the process without compromising accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic analysis of [18F]FAZA in non-small cell lung cancer patients. Verwer, EE., van Velden, FH., Bahce, I., et al.[2021]

The novel azomycin nucleosides beta-2-FAZA and beta-3-FAZL were synthesized and showed similar radiosensitization properties to the existing PET tracer FAZA, with sensitizer enhancement ratios of about 1.8 in HCT-116 cancer cells.

These new compounds have slightly lower partition coefficients than FAZA, which may influence their uptake and effectiveness in imaging tumor hypoxia, potentially improving the diagnosis and treatment of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and hypoxia selective radiosensitization potential of beta-2-FAZA and beta-3-FAZL: fluorinated azomycin beta-nucleosides. Kumar, P., Emami, S., Kresolek, Z., et al.[2019]

In a pilot study involving 11 patients with laryngeal squamous cell carcinoma, (18)F-FAZA-PET/CT scans detected hypoxic regions in 9 out of 11 tumors, indicating its potential utility in identifying tumor hypoxia.

However, the study found no clear correlation between (18)F-FAZA uptake and established hypoxia markers, suggesting that further research is needed to validate the accuracy of (18)F-FAZA-PET for guiding radiotherapy planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of hypoxic subvolumes in laryngeal cancer with (18)F-fluoroazomycinarabinoside ((18)F-FAZA)-PET/CT scanning and immunohistochemistry. Bruine de Bruin, L., Bollineni, VR., Wachters, JE., et al.[2019]

In a study involving 9 non-small cell lung cancer patients, both Logan graphic analysis and spectral analysis provided highly accurate quantifications of (18)F-FAZA uptake, correlating well with traditional nonlinear regression methods.

The study found that while tumor-to-blood ratios (SUVr) were comparable, they exhibited significant bias at high volumes of distribution, suggesting that parametric methods may be more reliable for precise hypoxia imaging in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parametric methods for quantification of 18F-FAZA kinetics in non-small cell lung cancer patients. Verwer, EE., Bahce, I., van Velden, FH., et al.[2017]

In a study involving 10 patients with advanced non-small cell lung cancer, the relationship between tumor blood flow (TBF) and the uptake of the PET tracer (18)F-FAZA was explored, revealing that decreased TBF does not always correlate with lower (18)F-FAZA uptake, indicating a more complex interaction than previously thought.

The findings suggest that areas of high (18)F-FAZA uptake can exist alongside high TBF, challenging the assumption that hypoxia (indicated by (18)F-FAZA uptake) is solely linked to low perfusion, and highlighting the importance of multiparametric analysis in understanding tumor biology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric Analysis of the Relationship Between Tumor Hypoxia and Perfusion with ¹⁸F-Fluoroazomycin Arabinoside and ¹⁵O-H₂O PET. Iqbal, R., Kramer, GM., Verwer, EE., et al.[2017]

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/5569b7ec3e16bcaf/nct04560036-hypoxia-measurement-faza-pet-mri-metastasized-gastro-oesophageal-cancer

FAZA PETMRI Gastro-Oesophageal Study | MedPath This is a single arm, pilot study of PET/MRI scan with radiotracer 18F-Fluoroazomycin Arabinoside (FAZA) before and after standard of care platinum-based ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5842657/

Hypoxia imaging with 18F-FAZA PET/CT predicts ... A T/B ≥ 3.59 on pre-treatment 18F-FAZA PET/CT was predictive for worse RT response (sensitivity 92.3%, specificity 71.4%). Radiation was less ...

3. mdpi.com mdpi.com/2379-139X/10/9/102

18F-Fluoroazomycin Arabinoside (FAZA) PET/MR as a ... Imaging of hypoxia in LARC with 18 F-FAZA PET/MR is feasible. Blood pool as measured in the LV appears to be the most reliable reference for calculating the HF.

4. ancora.ai ancora.ai/de/details/NCT04560036

FAZA PETMRI Gastro-Oesophageal Study (NCT04560036) This is a single arm, pilot study of PET/MRI scan with radiotracer 18F-Fluoroazomycin Arabinoside (FAZA) before and after standard of care platinum-based ...

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

Longitudinal tumor hypoxia imaging with [18F]FAZA-PET ... Non-invasive measurement of tumor hypoxia has demonstrated potential for the evaluation of disease progression, as well as prediction and ...

6. withpower.com withpower.com/trial/phase-neoplasm-metastasis-8-2020-6cbe3

FAZA PET/MRI Scan for Gastroesophageal Cancer A radiotracer called 18F-Fluoroazomycin Arabinoside (FAZA) is used as a type of "dye" in the PET/MRI scan.The primary goal of the study is to validate FAZA PET/ ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03168737

18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing ... Using 18F-fluoroazomycin arabinoside with PET-CT may help doctors plan better treatment for patients with solid tumors. 18F-fluoroazomycin arabinoside may help ...

8. withpower.com withpower.com/trial/phase-1-breast-neoplasms-8-2017-f1484

18F-AZA PET-CT Imaging for Cancer Diagnosis Is 18F-AZA PET-CT Imaging safe for humans? The studies on 18F-fluoroazomycin arabinoside (FAZA) primarily focus on its use as a PET tracer for identifying tumor ...