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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for diagnosing solid tumors using a PET-CT scan combined with 18F-fluoroazomycin arabinoside, a radioactive tracer. Researchers aim to determine if this method can reveal the oxygen levels in a tumor, potentially improving treatment planning. The trial seeks participants diagnosed with a solid tumor, such as breast, pancreatic, or colorectal cancer, who have not received treatment in the last month. Participants will undergo multiple PET-CT scans to obtain detailed images of their tumors. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to experience this innovative diagnostic approach.

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 prior data suggests that 18F-fluoroazomycin arabinoside PET-CT imaging is safe for diagnosing solid tumors?

Research shows that 18F-fluoroazomycin arabinoside, when used with PET-CT scans, remains in the early stages of human safety testing. As this is an early phase study, detailed safety information is not yet available. These initial trials typically aim to determine the treatment's safety and identify any side effects. So far, no serious side effects have been widely reported with this imaging agent. However, as this is a new and experimental method, unknown risks may still exist. Participants should discuss any concerns with their healthcare providers before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new imaging technique using 18F-fluoroazomycin arabinoside (18F-AZA) in PET-CT scans to diagnose cancer. Unlike traditional imaging options, which might not always clearly highlight tumor hypoxia, 18F-AZA specifically targets low-oxygen areas in tumors, potentially offering a more accurate picture of the cancer's environment. This technique could help doctors better understand tumor behavior and tailor treatments more effectively, leading to personalized cancer care.

What evidence suggests that 18F-fluoroazomycin arabinoside PET-CT is effective for diagnosing solid tumors?

Research shows that 18F-fluoroazomycin arabinoside, when used with PET-CT scans, might aid in diagnosing solid tumors by revealing the tumor's oxygen levels. This trial will evaluate the effectiveness of this method. Participants in Group A will undergo PET-CT scans at specific intervals on days 1 and 2, while participants in Group B will have scans on day 1 and again up to 10 days later. Studies suggest that knowing a tumor's oxygen levels is crucial, as it can affect the tumor's response to treatments. In other research, this method has helped create better treatment plans for cancer patients. Although still in the early stages, the aim is to help doctors see and understand tumors more clearly, potentially leading to better treatment decisions. ^{1 3 6 7 8}

Who Is on the Research Team?

Franklin C. Wong

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

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

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.

I am not allergic to [18F] FAZA.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4714693/

Prognostic value of 18F‐fluoroazomycin arabinoside PET ... This study evaluated the prognostic value of positron emission tomography/computed tomography (PET/CT) using 18F‐fluoroazomycin arabinoside ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03168737

18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing ... This early phase I trial studies how well 18F-fluoroazomycin arabinoside positron emission tomography (PET)-computed tomography (CT) works in diagnosing ...

3. withpower.com withpower.com/trial/phase-1-breast-neoplasms-8-2017-f1484

18F-AZA PET-CT Imaging for Cancer Diagnosis Using 18F-fluoroazomycin arabinoside with PET-CT may help doctors plan better treatment for patients with solid tumors. 18F-fluoroazomycin arabinoside may help ...

4. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/fluorine-f-18-fluoroazomycin-arabinoside

Clinical Trials Using Fluorine F 18-fluoroazomycin ... NCI supports clinical trials that test new and more effective ways to treat cancer. Find clinical trials studying fluorine f 18-fluoroazomycin arabinoside.

5. researchgate.net researchgate.net/publication/236933587_Comparison_of_F-18-Fluoroazomycin-Arabinofuranoside_and_Cu-64-Diacetyl-BisN4-Methylthiosemicarbazone_in_Preclinical_Models_of_Cancer

Comparison of F-18-Fluoroazomycin-Arabinofuranoside ... In the present study, we analyzed intratumoral distributions of FAZA and Cu-ATSM in xenograft tumors induced by cancer cell lines of various origin and cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4250522/

PET probes beyond 18F-FDG - PMC In this review, we briefly summarize the representative PET probes beyond 18 F-FDG that are available for patients imaging in three major clinical areas.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0001299822000526

Current Knowledge and Perspectives in Lung Cancer The most commonly used PET tracer is fluorine-18 (18F) bound to the glucose analogue 2-[18F]fluoro-2-deoxy-D-glucose ([18F]FDG). The basis for imaging with [18F] ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3060704/

Positron Emission Tomography Imaging of Cancer Biology This review provides an overview of the current status and trends in the development of non-[ 18 F]FDG PET probes in oncology and their application in the ...