TheranosticTrials.org

Clinical Trial · NCT05394259

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

Overview

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

Sponsor

MD Anderson Cancer Center

Phase

Phase 1

Contacts

Yang Lu, MD, PHD (CONTACT)

ylu10@mdanderson.org

(713) 792-5768

Yang Lu, MD, PHD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05394259

Drug / Compound

PSMA-1007

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • 1. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of PYLARIFY in patients \<18 years of age, children are excluded from this study.
  • ECOG performance status ≤2 (Karnofsky ≥60%,).
  • Subject or subject's Legally Authorized Representative (LAR) is able to understand, willing and able to provide written informed consent.
  • Patients must have histologically or cytologically confirmed pancreatic ductal adenocarcinoma, HCC and invasive lobular carcinoma
  • Patients with either: a) clinical or radiological (SoC CT, or MRI or FDG PET-CT tests) suspicion of metastatic disease; or b) proven metastatic disease but in whom there is suspicion of an even greater tumor burden that could change therapy approach.

Exclusion

  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients who have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to PYLARIFY (piflufolastat F18) injection.
  • History of allergic reactions to PSMA PET radiopharmaceuticals.
  • 1. Pregnant or breastfeeding during participation in the study are excluded because: There is no information on the risk of adverse developmental outcomes in pregnant women or animals with the use of piflufolastat F18. All radiopharmaceuticals, including PYLARIFY, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose; There is no information on the presence of piflufolastat F18 in human milk, the effect on the breastfed infant, or the effect on milk production.
  • Unable to lie flat during or tolerate PET-CT