FAZA PET-MRI for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Investigational agents

Disqualifiers: Prior RT, Metastases, Uncontrolled illness, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method to understand pancreatic cancer that cannot be surgically removed. Researchers aim to determine if a special type of PET scan combined with an MRI, called FAZA PET-MRI, can effectively measure oxygen levels reaching the cancer cells. Individuals with non-removable, non-metastatic pancreatic cancer scheduled for radiation treatment may qualify for this study. Participants will undergo these scans before and after their standard cancer treatment to assess the approach's effectiveness and safety. As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance future cancer imaging techniques.

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

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving other investigational agents.

What prior data suggests that the FAZA PET-MRI technique is safe for measuring hypoxia in pancreatic cancer patients?

Research has shown that FAZA, a new substance used in special PET scans, was tested in past studies to detect low oxygen levels in pancreatic cancer. These studies reported no major side effects, suggesting that FAZA is generally safe for people. Although detailed safety information from these studies is limited, the absence of serious problems in earlier research reassures about the safety of FAZA PET-MRI. However, as with any new treatment, monitoring for side effects during the trial remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FAZA PET-MRI technique for pancreatic cancer because it offers a new way to visualize and assess tumors. Unlike traditional imaging methods, this technique combines PET and MRI scans to provide detailed images of cancer metabolism and structure simultaneously. This could help doctors tailor radiation treatments more precisely, potentially improving outcomes for patients by targeting the cancer more effectively and minimizing damage to healthy tissue.

What evidence suggests that FAZA PET-MRI is effective for measuring hypoxia in pancreatic cancer?

Research has shown that FAZA PET-MRI can effectively detect low oxygen levels in pancreatic tumors. One study found that this imaging method successfully identified areas with low oxygen in pancreatic cancer, which is important because these areas often resist standard treatments. Another study demonstrated that FAZA-PET can track changes in tumor oxygen levels before and after radiation therapy. This capability might help doctors assess the effectiveness of the radiation. Overall, FAZA PET-MRI appears to be a promising tool for understanding and treating pancreatic cancer. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-metastatic, locally advanced pancreatic cancer that can't be surgically removed but hasn't spread elsewhere. They should have had prior therapy and still qualify for stereotactic body radiation therapy (SBRT). Pregnant women or those with previous upper abdomen radiation, other active cancers, MRI contraindications, or serious health issues are excluded.

Inclusion Criteria

My pancreatic cancer is new, cannot be surgically removed, but can be treated with SBRT.

I've had treatment for inoperable pancreatic cancer that's still localized and treatable with SBRT.

Women who can have babies need to have a test that shows they are not pregnant before getting the PET-MR imaging.

Exclusion Criteria

I have another cancer that is getting worse or was treated in the last 3 years.

Pregnant women

History or current evidence of any condition, therapy, or laboratory abnormality, known psychiatric or substance abuse disorders that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo FAZA PET-MRI scans to measure hypoxia before and after standard radiation treatment

Varies

2 visits (in-person)

Follow-up

Participants are followed up via telephone 48 hours after each imaging session to ensure the procedure was tolerated without side effects

48 hours after each imaging session

Telephone follow-up

Long-term Follow-up

Participants are monitored for tumor hypoxia over a period of 2.5 years

2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• FAZA
• Standard of Care Radiation Treatment

Trial Overview The study tests FAZA-PET combined with MRI to measure oxygen levels in tumors of up to 20 patients before and after standard radiation treatment. FAZA is a new type of PET scan tracer. The goal is to see how well this imaging technique works in assessing tumor hypoxia in pancreatic cancer.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10175752/

The progress of PET/MRI in clinical management ... This review summarizes the value of PET/MRI in the diagnosis, staging, efficacy monitoring, and prognosis evaluation of pancreatic cancer

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04395469

Study Details | NCT04395469 | FAZA PET/MRI Pancreas A compelling study has found the presence of hypoxia in pancreatic tumors using FAZA-PET imaging. The data derived from this alternative dual-imaging approach ...

3. nature.com nature.com/articles/s41598-019-57364-0

Quantifying Reoxygenation in Pancreatic Cancer During ... We used fluoro-5-deoxy-α-D-arabinofuranosyl)-2-nitroimidazole positron-emission tomography (FAZA-PET) imaging to quantify hypoxia before and after 5-fraction ...

4. link.springer.com link.springer.com/article/10.1007/s11307-019-01374-x

Longitudinal PET Imaging to Monitor Treatment Efficacy by ... In this study, we investigated the value of [18F]FAZA-PET in assessing the baseline levels of hypoxia in two orthotopic patient-derived tumor ...

5. npcf.us npcf.us/clinical-trials/a-study-using-18f-faza-and-pet-scans-to-study-hypoxia-in-pancreatic-cancer/

A Study Using 18F-FAZA And PET Scans To ... This is a diagnostic study to look for low levels of oxygen (hypoxia) in pancreatic cancer using an imaging test called positron emission tomography (PET).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01542177

A Study Using 18F-FAZA and PET Scans to Study Hypoxia ... This is a diagnostic study to look for low levels of oxygen (hypoxia) in pancreatic cancer using an imaging test called positron emission tomography (PET).

7. withpower.com withpower.com/trial/phase-adenocarcinoma-4-2021-2f8a3

FAZA PET-MRI for Pancreatic Cancer · Info for Participants FAZA is an investigational radiotracer used in PET scans. FAZA PET-MRI will be used to measure hypoxia in up to 20 patients with unresectable, non-metastatic, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4610963/

Longitudinal tumor hypoxia imaging with [18F]FAZA-PET ... Here, we report the use of FAZA-PET for repeated and longitudinal monitoring of tumor hypoxia changes in a mouse xenograft model of HT-29 ...