18F-FAZA PET Scan for Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Alex Sun, MD, FRCPC

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

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a special scan with a special substance to find low oxygen levels in lung cancer tumors. It targets lung cancer patients about to start treatment. The special substance highlights low-oxygen areas in the tumor, helping doctors understand the tumor better. The special substance has been used in various studies to evaluate low oxygen areas within tumors.

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 data supports the effectiveness of the drug 18F-FAZA for lung cancer?

Research shows that 18F-FAZA is effective in identifying low-oxygen areas within tumors, which is important for diagnosing and treating cancer. It has good image contrast and is used in PET scans to help doctors see these hypoxic regions clearly. ^{1 2 3 4 5}

Is 18F-FAZA safe for use in humans?

Research indicates that a 370-MBq injection of 18F-FAZA is safe for clinical use, with radiation doses similar to other commonly used PET tracers. The highest radiation exposure is to the bladder wall, but overall, the effective dose is comparable to other hypoxia tracers. ^{1 2 4 5 6}

How does the drug 18F-FAZA differ from other lung cancer treatments?

18F-FAZA is unique because it is a PET scan tracer specifically designed to identify hypoxic (low oxygen) regions within tumors, which can be crucial for understanding tumor behavior and planning treatment. Unlike other treatments that may target cancer cells directly, 18F-FAZA helps visualize areas of the tumor that are not getting enough oxygen, providing valuable information for treatment planning. ^{1 2 4 5 7}

Eligibility Criteria

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

Age ≥ 18 years

Concurrent systemic therapy allowed

Ability to provide written informed consent to participate in the study

Exclusion Criteria

Failure to provide written informed consent

Pregnancy

Age less than 18 years old

Trial Timeline

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

Treatment Details

Interventions

• 18-F-FAZA (Radiopharmaceutical)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University Health Network, Princess Margaret Cancer Centre Toronto, Canada

Who Is Running the Clinical Trial?

University Health Network, Toronto Lead Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetic analysis of [18F]FAZA in non-small cell lung cancer patients. [2021] [(18)F]Fluoroazomycin arabinoside (FAZA) is a positron emission tomography (PET) tracer developed to enable identification of hypoxic regions within a tumour. The aims of this study were to determine the optimal kinetic model along with validation of using alternatives to arterial blood sampling for analysing [(18)F]FAZA studies and to assess the validity of simplified analytical methods.

2. Ireland pubmed.ncbi.nlm.nih.gov

Assessment of hypoxic subvolumes in laryngeal cancer with (18)F-fluoroazomycinarabinoside ((18)F-FAZA)-PET/CT scanning and immunohistochemistry. [2019] (18)F-fluoroazomycinarabinoside ((18)F-FAZA) is a promising hypoxia radiopharmaceutical agent with outstanding biokinetic parameters. We aimed to determine the accuracy of (18)F-FAZA-PET/CT scan in detecting hypoxic regions within the tumor using immunohistochemical markers in a pilot study.

3. United States 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. [2017] Label="INTRODUCTION" NlmCategory="BACKGROUND">Radiolabeled 2-nitroimidazoles (azomycins) are a prominent class of biomarkers for PET imaging of hypoxia. [18F]Fluoro-azomycin-α-arabinoside ([18F]FAZA) - already in clinical use - may be seen as α-configuration nucleoside, but enters cells only via diffusion and is not transported by cellular nucleoside transporters. To enhance image contrast in comparison to [18F]FAZA our objective was to 18F-radiolabel an azomycin-2´-deoxyriboside with β-configuration ([18F]FAZDR, [18F]-β-8) to mimic nucleosides more closely and comparatively evaluate it versus [18F]FAZA.

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

Multiparametric Analysis of the Relationship Between Tumor Hypoxia and Perfusion with ¹⁸F-Fluoroazomycin Arabinoside and ¹⁵O-H₂O PET. [2017] (18)F-fluoroazomycin arabinoside ((18)F-FAZA) is a PET tracer of tumor hypoxia. However, as hypoxia often is associated with decreased perfusion, the delivery of (18)F-FAZA may be compromised, potentially disturbing the association between tissue hypoxia and (18)F-FAZA uptake. The aim of this study was to gain insight into the relationship between tumor perfusion and (18)F-FAZA uptake.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Synthesis and hypoxia selective radiosensitization potential of beta-2-FAZA and beta-3-FAZL: fluorinated azomycin beta-nucleosides. [2019] (18)F-Labelled fluoroazomycin arabinoside ([(18)F]FAZA) is a 2-nitroimidazole (azomycin) based PET tracer used extensively in cancer clinics to diagnose tumour hypoxia. The hypoxia-specific uptake and rapid blood clearance kinetics of FAZA contribute to good tumor-to-background ratios (T/B ratios) and high image contrast. However, FAZA, an alpha-configuration nucleoside, is not transported by cellular nucleoside transporters. It enters cells only via diffusion, therefore not achieving the high uptake and T/B ratios characteristic of actively transported radiopharmaceuticals. The present work describes the synthesis, physicochemical properties and preliminary assessment of the radiosensitization properties of two novel azomycin nucleosides, 1-beta-D-(2-deoxy-2-fluoroarabinofuranosyl)-2-nitroimidazole (beta-2-FAZA) and 1-beta-D-(3-deoxy-3-fluorolyxofuranosyl)-2-nitroimidazole (beta-3-FAZL) (fluorination yields 60% and 55%, respectively). The tosylated precursors required to synthesize the corresponding F-18 labeled radiopharmaceuticals are also reported. The partition coefficients (P) for beta-2-FAZA (1.0) and beta-3-FAZL (0.95) were marginally lower than reported for FAZA (1.1). The radiosensitization properties of both these compounds are similar to that of FAZA, with sensitizer enhancement ratios (SER) of approximately 1.8 for HCT-116 cells.

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

First Evaluation of PET-Based Human Biodistribution and Dosimetry of 18F-FAZA, a Tracer for Imaging Tumor Hypoxia. [2018] 18F-labeled fluoroazomycinarabinoside (18F-FAZA) is a PET biomarker for noninvasive identification of regional tumor hypoxia. The aim of the present phase I study was to evaluate the biodistribution and dosimetry of 18F-FAZA in non-small cell lung cancer patients. Methods: Five patients awaiting surgical resection of histologically proven or radiologically suspected non-small cell lung cancer were prospectively enrolled in the study. The patients underwent PET/CT after injection of 371 ± 32 MBq of 18F-FAZA. The protocol consisted of a 10-min dynamic acquisition of the heart to calculate the activity in blood, followed by 4 whole-body PET/CT scans, from the vertex to the mid thigh, at 10, 60, 120, and 240 min after injection. Urine samples were collected after each imaging session and at 360 min after injection. Volumes of interest were drawn around visually identifiable source organs to generate time-activity curves. Residence times were determined from time-activity curves, and effective doses to individual organs and the whole body were calculated using OLINDA/EXM 1.2 for the standard male and female phantoms. Results: Blood clearance was characterized by a rapid distribution followed by first-order elimination. The highest uptake was in muscle and liver, with respective percentage injected activity (%IA) peaks of 42.7 ± 5.3 %IA and 5.5 ± 0.6 %IA. The total urinary excretion was 15 %IA. The critical organ, with the highest absorbed radiation doses, was the urinary bladder wall, at 0.047 ± 0.008 and 0.067 ± 0.007 mGy/MBq for the 2- and 4-h voiding intervals, respectively. The effective doses for the standard male and female phantoms were 0.013 ± 0.004 and 0.014 ± 0.004 mSv/MBq, respectively, depending on the voiding schedule. Conclusion: With respect to the available literature, the biodistribution of 18F-FAZA in humans appeared to be slightly different from that in mice, with a low clearance in humans. Therefore, use of animal data may moderately underestimate radiation doses to organs in humans. 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 dose is not appreciably different from those obtained with other hypoxia tracers, such as 18F-fluoromisonidazole.

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

Parametric methods for quantification of 18F-FAZA kinetics in non-small cell lung cancer patients. [2017] (18)F-fluoroazomycinarabinoside ((18)F-FAZA) is a hypoxia-specific PET tracer. In future clinical applications of hypoxia imaging, such as early response monitoring or radiation therapy dose painting, accurate quantification of tracer uptake at the voxel level will be required. The aim of the present study was to assess the validity of parametric methods for the quantification of (18)F-FAZA studies.