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.
Phase I Study of 203Pb-RMX-VH-PIB Dosimetry and Biodistribution in Patients With Solid Tumors Like GBM and PDAC
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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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, e.g., ~1-2 h, 4-6 h, 24 h, 48 h, 120 h, 144h (conditional).
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 to 72 hours post-injection (multi-time-point SPECT/CT, e.g., ~1-2 h, 4-6h, 24 h, 48 h, 120h, 144h conditional)
For each subject, VOIs are drawn over critical organs (e.g., kidneys, liver, spleen, red marrow, pancreas, brain, thyroid, salivary glands) and target lesions. Time-activity curves are fit and residence times derived; absorbed dose per injected activity is computed with a standard MIRD schema (e.g., OLINDA/EXM or equivalent)