A Pilot Study to Assess the Clinical Utility of PYLARIFY PET-CT for Detecting Metastasis in Pancreatic Cancer, Hepatocellular Carcinoma and Breast Cancer
M.D. Anderson Cancer Center
Summary
To learn if piflufolastat F18 can be used in imaging scans for patients with breast cancer, HCC, or pancreatic cancer
Description
Primary Objective: * To assess the diagnosis accuracy of PYLARIFY (piflufolastat F18 ) PET-CT for imaging patients with suspected metastatic pancreatic cancer, hepatocellular carcinoma (HCC) and breast cancer. Accuracy is defined as the number of concordant cases between PYLARIFY PET-CT and the gold standard truth divided by the total sample size Secondary Objectives: * To assess diagnosis accuracy of PYLARIFY (piflufolastat F18 ) PET-CT for imaging patients with suspected metastatic pancreatic cancer, hepatocellular carcinoma (HCC) and breast cancer by additional accuracy measures includin…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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. 2. ECOG performance status ≤2 (Karnofsky ≥60%,). 3. Subject or subject's Legally Authorized Representative (LAR) is able to understand, willing and able to provide written informed consent. 4. Patients must have histologically or cytologically confirmed pancreatic ductal adenocarcinoma, HCC and invasive lobular carcinoma 5. Patients with either: a) clinical or radiological (SoC CT, or MRI or FDG PET-C…
Interventions
- DrugPiflufolastat F18
Given by vein (IV)
Location
- MD Anderson Cancer CenterHouston, Texas