18F-FAZA PET Scan for Lung Cancer

Overseen By Stephen Breen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

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

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how low oxygen levels, known as hypoxia, affect lung cancer growth and treatment response. Researchers will use a PET scan with a special tracer called 18F-FAZA (fluoroazomycin arabinoside) to determine if it can effectively measure hypoxia in lung tumors. This approach might be simpler than other methods and could offer valuable insights for future treatments. It is suitable for those with stage II or III lung cancer who plan to undergo radiotherapy. Participants will receive one 18F-FAZA PET scan before their first radiotherapy session. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could shape future lung cancer treatments.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, it does allow for concurrent systemic therapy, which suggests you may be able to continue some treatments.

What prior data suggests that this PET scan is safe for measuring hypoxia in lung cancer?

Research has shown that the radiotracer 18F-FAZA has been safely used in many cancer patients, including those with lung cancer. In earlier studies, 18F-FAZA helped doctors use PET scans to detect low oxygen levels in tumors. These scans assist doctors in assessing how a tumor might respond to treatments.

The safety record for 18F-FAZA is generally positive. It is already used in medical settings to diagnose various solid tumors. Studies have shown that patients tolerate it well, with no major side effects reported. This suggests that 18F-FAZA is a safe option for those considering participation in a trial using this PET scan method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-FAZA PET scan for lung cancer because it offers a new way to visualize hypoxic (oxygen-deprived) areas within tumors, which are often resistant to traditional treatments like chemotherapy and radiation. Unlike standard imaging techniques that might not clearly differentiate these zones, 18F-FAZA is a radiotracer that specifically highlights hypoxic regions. This targeted approach can help doctors tailor treatment plans more effectively, potentially leading to better outcomes for patients.

What evidence suggests that the 18F-FAZA PET scan is effective for assessing hypoxia in lung cancer?

Research has shown that the radiotracer 18F-FAZA effectively images low oxygen levels in tumors. Studies have demonstrated its success in highlighting these low-oxygen areas in cancers, including non-small cell lung cancer. This is crucial because low oxygen in tumors can affect their response to treatments like chemotherapy and radiotherapy. In this trial, all participants will receive an 18F-FAZA PET Scan before their first radiation therapy session. Initial findings in lung cancer patients have been promising, showing that 18F-FAZA clearly visualizes tumor oxygen levels. This makes it a valuable tool for doctors to better plan cancer treatments by understanding tumor behavior. ^{1 2 4 6 7}

Who Is on the Research Team?

Alex Sun, MD, FRCPC

Principal Investigator

The Princess Margaret Cancer Foundation

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage II or III lung cancer who are set to receive radiotherapy. It's open to those with both non-small cell (NSCLC) and small cell lung cancer (SCLC), even if they're getting other treatments too. Women must test negative for pregnancy before the PET scan, and all participants need to be able to lie on their back for an hour and give written consent.

Inclusion Criteria

Concurrent systemic therapy allowed

Ability to provide written informed consent to participate in the study

You have stage II or III lung cancer and may need radiation therapy for the main tumor or nearby lymph nodes.

Exclusion Criteria

Failure to provide written informed consent

Pregnancy

You have received radiation therapy to the areas where the treatment will be given.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive a FAZA PET Scan to measure hypoxia in the tumor

1 day

1 visit (in-person)

Radiotherapy

Participants undergo radiotherapy treatment following the PET scan

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18-F-FAZA

Trial Overview The study tests a PET scan using a tracer called FAZA that detects low oxygen levels in tumors, which can affect how well cancer responds to treatment. Participants will have one FAZA PET scan before starting radiotherapy, aiming to see if this method offers better insights into tumor hypoxia than current techniques.

How Is the Trial Designed?

Group I: 18-F-FAZA Scan Experimental Treatment 1 Intervention

All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction

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 phase I study involving five patients with non-small cell lung cancer demonstrated that 18F-FAZA is safe for clinical use, with effective radiation doses comparable to other commonly used PET tracers, indicating its potential for noninvasive tumor hypoxia identification.

The biodistribution of 18F-FAZA showed significant uptake in muscle and liver, with the urinary bladder wall receiving the highest radiation dose, suggesting careful consideration of organ exposure during its clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Evaluation of PET-Based Human Biodistribution and Dosimetry of 18F-FAZA, a Tracer for Imaging Tumor Hypoxia. Savi, A., Incerti, E., Fallanca, F., et al.[2018]

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]

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]

The newly developed radiolabeled azomycin-2'-deoxyriboside ([18F]FAZDR) demonstrated significantly higher tumor contrast in PET imaging compared to the existing [18F]FAZA, particularly at earlier time points after injection, indicating its potential for improved imaging of hypoxia in tumors.

[18F]FAZDR showed a unique response to oxygen levels, with tracer uptake in tumors inversely correlating with oxygen breathing, suggesting that it may provide more mechanistic insights into tumor hypoxia compared to [18F]FAZA, which relies solely on passive diffusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]Fluoro-azomycin-2´-deoxy-β-d-ribofuranoside - A new imaging agent for tumor hypoxia in comparison with [18F]FAZA. Schweifer, A., Maier, F., Ehrlichmann, W., et al.[2017]

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]

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]

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]

Citations

1. link.springer.com link.springer.com/chapter/10.1007/978-3-031-10271-4_8

18F-Fluoroazomycin Arabinoside (FAZA) Clinical Utility. Hypoxia imaging. Promising preliminary results in head and neck squamous cell carcinoma, non-small cell lung carcinoma, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4835394/

An exploratory study of volumetric analysis for assessing ... An exploratory study of volumetric analysis for assessing tumor response with 18F-FAZA PET/CT in patients with advanced non-small-cell lung ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28294075/

18F]Fluoro Azomycin Arabinoside (β -[18F]FAZA): ... 18F FAZA is a PET radiotracer that demonstrates excellent potential in imaging regional hypoxia, and is clinically used in diagnosing a wide range of solid ...

4. researchgate.net researchgate.net/publication/365048558_18F-Fluoroazomycin_Arabinoside_FAZA

18F-Fluoroazomycin Arabinoside (FAZA) Initial results of hypoxia imaging using 1-alpha-D: -(5-deoxy-5-[18F]-fluoroarabinofuranosyl)-2-nitroimidazole ( 18F-FAZA) ... Of the 13 lung cancer patients (12 ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/58/8/1224

First Evaluation of PET-Based Human Biodistribution and ... Abstract. 18F-labeled fluoroazomycinarabinoside (18F-FAZA) is a PET biomarker for noninvasive identification of regional tumor hypoxia.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT02701699/18f-fluoroazomycin-arabinoside-18f-faza-in-lung-cancer

18F-Fluoroazomycin Arabinoside (18F-FAZA) in Lung ... The purpose of this study is to look for low levels of oxygen (hypoxia) in lung cancer using a positron emission tomography (PET) scan.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02701699?cond=Arabinoside&viewType=Table&rank=1

18F-Fluoroazomycin Arabinoside (18F-FAZA) in Lung ... Inclusion Criteria: Age ≥ 18 years; Patients with stage II or III lung cancer (both NSCLC and SCLC) qualifying for radiotherapy to the primary tumor, with or ...