PYLARIFY PET-CT Imaging for Cancer

Overseen by Yang Lu, MD, PHD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

To learn if piflufolastat F18 can be used in imaging scans for patients with breast cancer, HCC, or pancreatic cancer

Research Team

Yang Lu, MD, PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults with confirmed pancreatic ductal adenocarcinoma, hepatocellular carcinoma (HCC), or invasive lobular breast cancer who may have metastatic disease. Participants must be able to consent, have a measurable lesion, and an estimated life expectancy of at least 3 months. Pregnant women, those allergic to PSMA PET radiopharmaceuticals, or unable to undergo PET-CT are excluded.

Inclusion Criteria

My cancer may have spread, or there's a chance it has spread more than we thought.

I have not started treatment or my current treatment isn't working well, and I am scheduled for a biopsy.

You must have at least one spot that can be accurately measured to see if the treatment is working.

Exclusion Criteria

You have had allergic reactions to PSMA PET radiopharmaceuticals in the past.

I haven't had chemotherapy, immunotherapy, or radiotherapy in the last 4 weeks.

Pregnant or breastfeeding women.

Treatment Details

Interventions

• Piflufolastat F18 (Radiopharmaceutical)

Trial Overview The study is testing the effectiveness of piflufolastat F18 in detecting metastasis through imaging scans in patients with breast cancer, HCC, or pancreatic cancer. It aims to see if this can help assess tumor burden and influence treatment decisions.

Participant Groups

Group I: Piflufolastat F18 Experimental Treatment 1 Intervention

Piflufolastat F18 will first be given by vein over about 5 seconds.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Lantheus Medical Imaging

Industry Sponsor

Trials

57

Recruited

4,333,000+