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Phase I Study of 203Pb-RMX-VH-PIB Dosimetry and Biodistribution in Patients With Solid Tumors Like GBM and PDAC
Sponsor: Radiomedix, Inc.
Summary
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 IV injection of 203Pb-RMX-VH-PIB. Undergo multiple SPECT/CT imaging scans. Have blood, urine, vital signs, and ECG monitored for safety. Be followed for any side effects for up to 30 days.
Official title: Dosimetry and Bio-distribution of 203Pb-RMX-VH-PIB in Newly Diagnosed or Recurrent Patients With Solid Tumors: A Phase I Exploratory Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-08-15
Completion Date
2027-06-30
Last Updated
2026-07-29
Healthy Volunteers
No
Interventions
203Pb-RMX-VHPIB injection
A single intravenous (IV) injection of the investigational radiopharmaceutical 203Pb-RMX-VHPIB administered to eligible patients.
SPECT/CT Imaging
Serial whole-body and region-specific SPECT/CT scans performed after IP administration to assess biodistribution and dosimetry
Locations (1)
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, United States