Dosimetry and Bio-distribution of 203Pb-RMX-VH-PIB in Newly Diagnosed or Recurrent Patients With Solid Tumors: A Phase I Exploratory Study
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.
Description
This is an early-stage clinical trial designed to test a new imaging drug called 203Pb-RMX-VH-PIB. The study will use SPECT/CT scans to see how the drug spreads through the body and how much radiation is delivered to different organs. The trial will enroll 20 patients who have either glioblastoma multiforme (GBM), an aggressive brain tumor, or pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer. Patients may be newly diagnosed, have recurrent disease, or have stable tumors. For GBM patients, the drug's distribution will be compared with MRI scans to see if it highlights the tu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed informed consent. 2. Subjects aged ≥18 years. 3. Karnofsky status ≥60. 4. Negative urine pregnancy test in women of childbearing potential. 5. Histologically confirmed and /or highly suspicious GBM (Adult type Astrocytoma grade IV both IDH-Mutant and IDH-Wild Type) including primary, recurrent or stable enhancing residual or primary, recurrent or stable enhancing residual PDAC. a. GBM group i. Contrast enhanced Brain MRI image with results compatible with GBM within the 2 weeks of dosing day. ii. Tumor size of ≥ 1.0 cm in any dimension by MRI. iii. No ant…
Interventions
- Drug203Pb-RMX-VHPIB injection
A single intravenous (IV) injection of the investigational radiopharmaceutical 203Pb-RMX-VHPIB administered to eligible patients.
- Diagnostic TestSPECT/CT Imaging
Serial whole-body and region-specific SPECT/CT scans performed after IP administration to assess biodistribution and dosimetry
Location
- Excel Diagnostics & Nuclear Oncology CenterHouston, Texas