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

Part of paid clinical trials in Houston, Texas.

Sponsor
Radiomedix, Inc.
Study ID
NCT07733674
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 203Pb-RMX-VHPIB injection — DRUG
    A single intravenous (IV) injection of the investigational radiopharmaceutical 203Pb-RMX-VHPIB administered to eligible patients.
  • SPECT/CT Imaging — DIAGNOSTIC_TEST
    Serial whole-body and region-specific SPECT/CT scans performed after IP administration to assess biodistribution and dosimetry

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Aug 15, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 203Pb-RMX-VH-PIB Imaging
    All participants will receive a single intravenous injection of 203Pb-RMX-VH-PIB (5.0 ± 10% mCi). Following administration, participants will undergo multiple SPECT/CT scans to evaluate the biodistribution and radiation dosimetry of the investigational radiopharmaceutical. Safety assessments will include monitoring of vital signs, blood exams, and electrocardiograms (ECGs) before and after dosing, with adverse events recorded for up to 30 days.

Primary Outcome Measure

Whole-body and organ-specific absorbed radiation dose for 203Pb-RMX-VH-PIB [ Time Frame: From injection to up to 144 hours post-injection, multi-time-point SPECT/CT, e.g., ~1-2 h, 4-6 h, 24 h, 48 h, 120 h, 144h (conditional). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Excel Diagnostics & Nuclear Oncology CenterHoustonTexas77042
Susan Cork
[email protected]
713-781-6200
Nereyda Sauceda Sauceda
[email protected]
713-781-6200

Find similar trials in Houston, TX

By research site
Excel Diagnostics & Nuclear Oncology Center· Houston, TX

Related Studies