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Clinical Trial Summary

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


Clinical Trial 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 including sensitivity, specificity, negative predictive value and positive predictive value. - To evaluate the added clinical usefulness of PYLARIFY (piflufolastat F18) PET-CT for imaging patients with suspected metastatic pancreatic cancer, HCC and breast cancer. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05394259
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Yang Lu, MD, PHD
Phone (713) 792-5768
Email ylu10@mdanderson.org
Status Recruiting
Phase Phase 1
Start date October 28, 2022
Completion date January 1, 2025

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