The goal of this Phase I clinical trial is to evaluate how the imaging drug 203Pb- RMX-VH-PIB distributes in the body and how much radiation different organs receive in patients with glioblastoma multiforme (GBM) or pancreatic ductal adenocarcinoma (PDAC).
The main questions it aims to answer are:
How does 203Pb-RMX-VH-PIB spread in the body (biodistribution)? What is the radiation dose delivered to organs (dosimetry)?
Participants will:
Receive a single intravenous (IV) injection of 203Pb-RMX-VH-PIB. Undergo multiple single-photon emission computed tomography/computed tomography (SPECT/CT) imaging scans.
Have blood, urine, vital signs, and electrocardiogram (ECG) monitored for safety.
Be followed for any side effects for up to 30 days.
Signed informed consent.
Subjects aged ≥18 years.
Karnofsky status ≥60.
Negative urine pregnancy test in women of childbearing potential.
Known hypersensitivity to RMX-VH peptide analogue, 203Pb-RMX-VH-PIB, 203Pb (Lead) , or any of the excipients of 203Pb-RMX-VH-PIB.
Inability to undergo MRI or CT/SPECT/CT scans
Current somatic or psychiatric disease/condition that may interfere with consent or the objectives and assessments of the study.
Pregnancy or plans to conceive during the course of study participation.