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Recruiting Phase 1 NCT05394259

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

Trial Parameters

Condition Pancreatic Cancer
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 36
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-10-28
Completion 2027-02-02
Interventions
Piflufolastat F18

Brief Summary

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

Eligibility Criteria

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-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. 6. Patients with at least one measurable lesion on SoC imaging modality (CT, or MRI, or FDG PET-CT). Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension

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