Phase I Study of 203Pb-RMX-VH-PIB for Glioblastoma and Pancreatic Cancer Imaging
This early-stage study is looking at an imaging drug called 203Pb-RMX-VH-PIB. It aims to understand how this drug spreads throughout the body (biodistribution) and how much radiation different organs receive (dosimetry) in people with glioblastoma multiforme (GBM), a type of brain tumor, or pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer. You would receive a single injection of 203Pb-RMX-VH-PIB and have several SPECT/CT imaging scans. The study is looking for 20 participants aged 18 or older with these specific cancer types. The main goal is to see how the drug moves through the body and the radiation dose it delivers to organs.
- Study design
- This is an early-stage, interventional study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would receive a single intravenous injection of 203Pb-RMX-VH-PIB and undergo multiple SPECT/CT imaging scans. You would also have blood, urine, vital signs, and ECG monitored.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for any side effects for up to 30 days after the injection.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of 203Pb-RMX-VH-PIB Dosimetry and Biodistribution in Patients With Glioblastoma Multiform (GBM) and Pancreatic Ductal Adenocarcinoma (PDAC)
At a glance
Conditions
NCT07733674
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Excel Diagnostics & Nuclear Oncology Center
Houston, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Ebrahim Delpassand, MD, FACNM · STUDY_CHAIR · Radiomedix, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Whole-body and organ-specific absorbed radiation dose for 203Pb-RMX-VH-PIBFrom 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.
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.
- Organ-Specific Absorbed Dose of 203Pb-RMX-VH-PIBFrom 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.
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.