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RECRUITING
NCT07733674
PHASE1

Phase I Study of 203Pb-RMX-VH-PIB Dosimetry and Biodistribution in Patients With Solid Tumors Like GBM and PDAC

Sponsor: Radiomedix, Inc.

View on ClinicalTrials.gov

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

DRUG

203Pb-RMX-VHPIB injection

A single intravenous (IV) injection of the investigational radiopharmaceutical 203Pb-RMX-VHPIB administered to eligible patients.

DIAGNOSTIC_TEST

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