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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to understand cervical cancer behavior using a PET scan. The focus is on detecting low oxygen levels (hypoxia) in tumors, which might influence cancer growth and response to treatments like radiotherapy and chemotherapy. Researchers are testing a new imaging substance, 18F-Fluoroazomycin Arabinoside (18F-FAZA), to determine if it is more effective and user-friendly than older methods. Women diagnosed with certain types of cervical cancer who plan to receive radiotherapy, with or without chemotherapy, may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future cancer treatments.

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

Research has shown that 18F-Fluoroazomycin Arabinoside (18F-FAZA) is under study to measure oxygen levels in tumors. This is crucial because low oxygen levels can influence cervical cancer growth and treatment response. Studies have used 18F-FAZA to assess its effectiveness in detecting these low oxygen levels in cervical cancer patients.

Regarding safety, detailed information about side effects or adverse events for 18F-FAZA is not available. The trial is in a phase where human safety has not been fully established, meaning there might be limited information on treatment tolerance. Additionally, 18F-FAZA has not yet received approval from Health Canada for general use, indicating ongoing investigation for safety and effectiveness.

Prospective participants should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-Fluoroazomycin Arabinoside (18F-FAZA) because it offers a unique way to image tumor hypoxia in cervical cancer. Unlike standard imaging techniques like MRI or CT scans, which provide structural details, 18F-FAZA PET imaging targets hypoxic areas within the tumor, which are often more resistant to traditional treatments like chemotherapy and radiation. By pinpointing these oxygen-deficient regions, this method could potentially help doctors tailor more effective treatment plans for patients.

What evidence suggests that the FAZA PET scan is effective for detecting hypoxia in cervical cancer?

This trial will use a special imaging method called 18F-Fluoroazomycin Arabinoside (18F-FAZA) for PET scans in cervical cancer patients. This method identifies areas in the tumor with low oxygen levels, known as hypoxia, which can affect the cancer's response to treatment. Research has shown that PET/MRI scans are highly accurate for diagnosing cervical cancer, with an accuracy rate of nearly 95%, surpassing other imaging methods. Although the full benefits of 18F-FAZA are not yet completely understood, early signs suggest it could aid in understanding and treating cervical cancer. This imaging technology aims to simplify the assessment of tumor conditions, potentially leading to better treatment decisions. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Milosevic, MD

Principal Investigator

Princess Margaret Hospital, University Health Network

Are You a Good Fit for This Trial?

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

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

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20831481/

Evaluating repetitive 18F-fluoroazomycin-arabinoside ... PET imaging with (18)FAZA is feasible in patients with cancer of the uterine cervix. However, its predictive and prognostic value remains to be clarified.

2. medicaljournalssweden.se medicaljournalssweden.se/actaoncologica/article/view/32691/37597

View of Evaluating repetitive 18F-fluoroazomycin ... Dynamic and static 18FAZA -PET scans were performed before, during and after ... cervical cancer. There is much evidence that hypoxia represents an ...

3. researchgate.net researchgate.net/publication/46217985_Evaluating_repetitive_18F-fluoroazomycin-arabinoside_18FAZA_PET_in_the_setting_of_MRI_guided_adaptive_radiotherapy_in_cervical_cancer

Evaluating repetitive 18F-fluoroazomycin-arabinoside ... PET imaging with (18)FAZA is feasible in patients with cancer of the uterine cervix. However, its predictive and prognostic value remains to be ...

4. mdpi.com mdpi.com/2313-433X/11/2/63

Unraveling the Role of PET in Cervical Cancer PET/MRI demonstrated the highest diagnostic accuracy for cervical cancer (94.90%) compared to PET/CT, MRI, and CT (83.67%, 75.51%, and 69.39%, respectively) (p ...

5. academia.edu academia.edu/17538230/Evaluating_repetitive_18_F_fluoroazomycin_arabinoside_18_FAZA_PET_in_the_setting_of_MRI_guided_adaptive_radiotherapy_in_cervical_cancer?auto=download

Evaluating repetitive 18 F-fluoroazomycin-arabinoside ( 18 FAZA ... Background. The aim of this pilot study was to assess tumour hypoxia in patients with cervical cancer before, during and after combined radio-chemotherapy ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00388687

Hypoxia Imaging With 18F FAZA. Prognostic Impact in ... The aim of this study is to visualize the tumor hypoxic tissue, the potential quantitative changes and the biological behavior of cervical carcinoma ...

7. medicaljournalssweden.se medicaljournalssweden.se/actaoncologica/article/view/32691

Evaluating repetitive 18F-fluoroazomycin-arabinoside ... The aim of this pilot study was to assess tumour hypoxia in patients with cervical cancer before, during and after combined radio-chemotherapy ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01549730

Study Details | NCT01549730 | Cervix Hypoxia FAZA In this study, a dye called 18F-Fluoroazomycin Arabinoside (18F-FAZA) will be used to measure hypoxia levels in tumours. Health Canada has not approved FAZA for ...

9. 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.

10. tandfonline.com tandfonline.com/doi/full/10.3109/0284186X.2010.510145

Full article: Evaluating repetitive 18F-fluoroazomycin ... The aim of this pilot study was to assess tumour hypoxia in patients with cervical cancer before, during and after combined radio-chemotherapy ...