FAZA PET Scan for Cervical Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Disulfuram

Disqualifiers: Hysterectomy, Cervical stump, 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

30 Participants Needed

Trial Summary

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

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking the drug disulfuram (Antabuse).

What data supports the effectiveness of the drug 18F-Fluoroazomycin Arabinoside (18F-FAZA) for cervical cancer?

The drug 18F-FAZA is used as a PET tracer to identify low-oxygen areas in tumors, which is important for understanding tumor behavior and treatment planning. While specific effectiveness data for cervical cancer is not provided, 18F-FAZA has been shown to effectively identify tumor hypoxia in other cancers, like non-small cell lung cancer, suggesting it may be useful in similar ways for cervical cancer. ^{1 2 3 4 5}

Is the FAZA PET scan safe for humans?

The FAZA PET scan, using 18F-Fluoroazomycin Arabinoside, has been used in various cancer studies and is generally considered safe for humans. It is a PET tracer that helps identify low-oxygen areas in tumors, and studies have shown it has good imaging properties and clears from the blood quickly, which suggests it is well-tolerated. ^{1 2 4 5 6}

How does the FAZA PET scan differ from other treatments for cervical cancer?

The FAZA PET scan is unique because it uses a special tracer, (18)F-fluoroazomycin arabinoside, to identify low-oxygen areas in tumors, which can be important for understanding tumor behavior and treatment planning. Unlike other treatments that directly target cancer cells, this scan helps visualize tumor hypoxia (low oxygen levels), providing valuable information for personalized treatment strategies. ^{1 2 4 5 6}

What is the purpose of this trial?

The purpose of this study is to look for low levels of oxygen (hypoxia) in your cervix cancer using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have an effect on how cervix cancer grows and responds to treatments like radiotherapy and chemotherapy. Doctors at Princess Margaret Hospital have measured hypoxia in over 300 patients. The use of PET scans to measure hypoxia may be better and simpler than the methods used previously.

Research Team

Michael Milosevic, MD

Principal Investigator

Princess Margaret Hospital, University Health Network

Eligibility Criteria

This trial is for adults with cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) who plan to undergo radiotherapy and possibly chemotherapy. They should not have had previous cancer treatment and must be able to lie down for PET scans. Pregnant women are excluded.

Inclusion Criteria

My cancer is in stages 1 to 4, may have spread to nearby lymph nodes, and might or might not have spread to distant parts of the body.

I plan to undergo radiotherapy, possibly with cisplatin, for my condition as per PMH Gynecology Group's advice.

I can sign and understand the consent form for this study.

Exclusion Criteria

I have had a complete or partial hysterectomy.

I have cancer in the remaining part of my cervix after surgery.

I cannot lie on my back for more than 30 minutes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET FAZA imaging to assess tumor hypoxia

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Trial Overview The study tests a special x-ray test called a PET scan using 18F-Fluoroazomycin Arabinoside (18F-FAZA) to detect low oxygen levels in cervical cancer tissue, which may affect the tumor's growth and treatment response.

Participant Groups

Group I: PET FAZA imaging Experimental Treatment 1 Intervention

PET FAZA imaging of tumor hypoxia in patients with cervix cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

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 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]

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]

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]

References

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

Pharmacokinetic analysis of [18F]FAZA in non-small cell lung cancer patients. [2021]

2. 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]

3. 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]

4. 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]

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

Measurement of Tumor Hypoxia in Patients With Locally Advanced Cervical Cancer Using Positron Emission Tomography with 18F-Fluoroazomyin Arabinoside. [2019]

6. 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]