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Study of 203Pb-RMX-VH-PIB Dosimetry and Biodistribution in Patients With Glioblastoma Multiform (GBM) and Pancreatic Ductal Adenocarcinoma (PDAC)

NCT07733674 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-07

No results posted yet for this study

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 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.

Conditions

  • Glioblastoma Multiforme (GBM)
  • Pancreatic Ductal Adenocarcinoma (PDAC)

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

Sponsors & Collaborators

  • Radiomedix, Inc.

    lead INDUSTRY

Principal Investigators

  • Ebrahim Delpassand, MD, FACNM · Radiomedix, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07733674 on ClinicalTrials.gov