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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single arm, single centre, investigator initiated study to investigate the use of FAZA-PET in combination with MRI. 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, locally advanced un-resectable pancreatic adenocarcinoma (LAPAC). After each FAZA PET-MRI scan, patients will be followed up via telephone, 48 hours after the imaging session to assure that the procedure was tolerated without side effects. Patients will undergo a FAZA PET-MRI scans before and after their standard of care radiation treatment.

Eligibility Criteria

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

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

Treatment Details

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+