Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05394259

A Pilot Study to Assess the Clinical Utility of PYLARIFY PET-CT for Detecting Metastasis in Pancreatic Cancer, Hepatocellular Carcinoma and Breast Cancer

Led by M.D. Anderson Cancer Center · Updated on 2026-04-15

36

Participants Needed

1

Research Sites

222 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

L

Lantheus Medical Imaging

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

A Pilot Study to Assess the Clinical Utility of PYLARIFY PET-CT for Detecting Metastasis in Pancreatic Cancer, Hepatocellular Carcinoma and Breast Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • ECOG performance status of 2 or less (Karnofsky score 60% or higher)
  • Able and willing to provide written informed consent
  • Histologically or cytologically confirmed pancreatic ductal adenocarcinoma, hepatocellular carcinoma, or invasive lobular carcinoma of the breast
  • Clinical or radiological suspicion of metastatic disease or confirmed metastasis with possible greater tumor burden
  • At least one measurable lesion on standard imaging (CT, MRI, or FDG PET-CT) meeting size criteria
  • Ability and willingness to undergo biopsy or clinical follow-up as standard of care to confirm PET-CT findings
  • Either treatment naive or actively treated with suboptimal response and planned biopsy
  • Estimated life expectancy of at least 3 months as determined by physician
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of allergic reactions to PSMA PET radiopharmaceuticals
  • Psychiatric illness or social situations limiting study compliance
  • Unable to lie flat or tolerate PET-CT scan
  • Received chemotherapy, immunotherapy, or radiotherapy within 4 weeks prior to PYLARIFY injection
  • Subjects with any medical condition or circumstance compromising safety or study compliance
  • Patients with other types of pancreatic, hepatic, or breast cancers besides those specified
  • Effect of androgen deprivation or related therapies on PYLARIFY PET is not established, consider carefully

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

Y

Yang Lu, MD, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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A Pilot Study to Assess the Clinical Utility of PYLARIFY PET-CT for Detecting Metastasis in Pancreatic Cancer, Hepatocellular Carcinoma and Breast Cancer | DecenTrialz