18F-AZA PET-CT Imaging for Cancer Diagnosis

Overseen By Franklin Wong

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Lactation, Allergy, Obesity, others

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

Compensation: Varies

Number of Visits: 25

Duration: 2 days

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not have received any systemic or local treatment for your tumor in the last month.

What data supports the effectiveness of the treatment 18F-AZA PET-CT Imaging for Cancer Diagnosis?

PET/CT imaging, which combines PET scans (a type of imaging that shows how tissues and organs are functioning) with CT scans (which provide detailed pictures of the inside of the body), is a powerful tool in cancer care. It helps in assessing the extent and severity of the disease and monitoring treatment response. While F-18-FDG is the most common tracer, other F-18 labeled tracers are being developed to study different aspects of tumors, potentially improving cancer diagnosis and management. ^{1 2 3 4 5}

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 hypoxia, but they do not provide specific safety data for humans. However, FAZA is already in clinical use, suggesting it has undergone some safety evaluations. ^{6 7 8 9 10}

How does 18F-AZA PET-CT imaging differ from other cancer diagnosis methods?

18F-AZA PET-CT imaging is unique because it uses a special tracer, 18F-fluoroazomycin arabinoside (FAZA), to detect low-oxygen areas in tumors, which are often more aggressive. Unlike other imaging methods, this tracer enters cells by diffusion and provides high image contrast, helping to identify hypoxic regions within tumors more effectively. ^{6 7 8 10 11}

What is the purpose of this trial?

This early phase I trial studies how well 18F-fluoroazomycin arabinoside positron emission tomography (PET)-computed tomography (CT) works in diagnosing solid tumors. Using 18F-fluoroazomycin arabinoside with PET-CT may help doctors plan better treatment for patients with solid tumors. 18F-fluoroazomycin arabinoside may help to show how much oxygen is present in a tumor during a PET-CT scan.

Research Team

Franklin C. Wong

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with solid tumors, especially those with breast, pancreatic, or colorectal cancer. Participants must not have had recent treatment for their tumor and should have a mass at least 1 cm in size. They need to understand and sign consent forms (or have a legal representative do so if necessary) and can't start other cancer treatments during the study. Pregnant women, individuals allergic to [18F] FAZA, those over 400 pounds or with high BMI that affects imaging quality are excluded.

Inclusion Criteria

My tumor is at least 1 cm wide, confirmed by imaging tests.

I, or my legal representative if I'm unable, understand and agree to participate in the study.

I haven't had any cancer treatment in the last month.

Exclusion Criteria

Pregnant or lactating women: pregnant women are excluded from this study because the effects of [18F] FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before accrual after informed consent is obtained.

If you weigh 400 pounds or more, or if your body size would affect the quality of the imaging tests, you cannot participate.

I am not allergic to [18F] FAZA.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients receive 18F-fluoroazomycin arabinoside IV and undergo PET-CT scans to evaluate tumor hypoxia

2 days

Multiple visits for PET-CT scans on days 1 and 2

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Follow-up visits at 24 hours and 30 days

Treatment Details

Interventions

• Computed Tomography
• Fluorine F 18-fluoroazomycin Arabinoside
• Positron Emission Tomography

Trial Overview The trial is testing how well an imaging compound called 18F-fluoroazomycin arabinoside works when used in PET-CT scans for diagnosing solid tumors. The goal is to see if this method can better indicate the oxygen levels in tumors which may help plan more effective treatments.

Participant Groups

Group I: Group B (18F-fluoroazomycin arabinoside, PET-CT scans) Experimental Treatment 3 Interventions

Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 or less PET-CT scans on day 1 and 5 or less PET-CT scans \>= 24 hours later up to 10 days.

Group II: Group A (18F-fluoroazomycin arabinoside, PET-CT scans) Experimental Treatment 3 Interventions

Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 PET-CT scans at 60, 90, 120, 150, and 180 minutes on days 1 and 2.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Diagnostic performance of PET/CT with tracers other than F-18-FDG in oncology: an evidence-based review. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Positron Emission Tomography: Current Role for Diagnosis and Therapy Monitoring in Oncology. [2019]

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

Differentiation of residual or recurrent tumors from post-treatment changes with F-18 FDG PET. [2016]

4. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

PET/CT in oncology: a major technology for cancer care. [2016]

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

PET/Computed Tomography in Breast Cancer: Can It Aid in Developing a Personalized Treatment Design? [2017]

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. 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]

8. 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]

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

PET imaging of tumor hypoxia using 18F-fluoroazomycin arabinoside in stage III-IV non-small cell lung cancer patients. [2017]

10. Japan pubmed.ncbi.nlm.nih.gov

Prognostic value of PET/CT with (18)F-fluoroazomycin arabinoside for patients with head and neck squamous cell carcinomas receiving chemoradiotherapy. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

An overview of radiolabeled amino acid tracers in oncologic imaging. [2023]