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.
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 tumor areas effectively. For PDAC patients, the study will track how the drug behaves in pancreatic tumors. Participants will be divided into four groups to study both biodistribution and dosimetry in each cancer type. Each participant will receive a single intravenous injection of the drug, followed by several whole-body SPECT/CT scans. To ensure safety, vital signs will be measured before and after the injection, and blood and urine samples will be collected at multiple time points. A 12-lead ECG will also be performed to monitor heart rhythm, and results will be reviewed by the investigator. Any side effects or health changes will be closely monitored and recorded for 30 days after administration. The goal of this exploratory study is to better understand how 203Pb-RMXVH- PIB works in the body and to gather important safety and radiation data in patients with GBM and PDAC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
A single intravenous (IV) injection of the investigational radiopharmaceutical 203Pb-RMX-VHPIB administered to eligible patients.
Serial whole-body and region-specific SPECT/CT scans performed after IP administration to assess biodistribution and dosimetry
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, United States
RECRUITINGWhole-body and organ-specific absorbed radiation dose for 203Pb-RMX-VH-PIB
Whole-body and organ-specific absorbed radiation doses will be estimated using serial quantitative SPECT/CT imaging and available blood and urine radioactivity data following a single intravenous administration of 203Pb-RMX-VH-PIB. Absorbed radiation doses will be summarized per unit of administered activity, such as mGy/MBq.
Time frame: From injection to up to 144 hours post-injection, multi-time-point SPECT/CT, approximately 1-2 hours, 4-6 hours, 24 hours, 48 hours, 120 hours, and, if needed, 144 hours after injection.
Organ-Specific Absorbed Dose of 203Pb-RMX-VH-PIB
For each participant, volumes of interest (VOIs) will be delineated over critical organs, including the kidneys, liver, spleen, red marrow, pancreas, brain, thyroid, and salivary glands, as well as target lesions. Time-activity curves will be fitted, and residence times will be derived. The absorbed dose per unit of injected activity will be calculated using the standard Medical Internal Radiation Dose (MIRD) schema with Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) software or an equivalent method.
Time frame: From injection to up to144 hours post-injection, multi-time-point SPECT/CT, approximately 1-2 hours, 4-6 hours, 24 hours, 48 hours, 120 hours, and, if needed, 144 hours after injection.
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