203Pb-RMX-VH-PIB Imaging for Brain Cancer
(RMX-VH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to observe how the new imaging drug, 203Pb-RMX-VH-PIB, travels through the body and the amount of radiation it delivers to various organs. It targets individuals with specific types of brain cancer (glioblastoma multiforme) or pancreatic cancer who have not recently undergone chemotherapy. Participants will receive a single IV injection of the drug and undergo several imaging scans, with health monitoring for up to 30 days to detect any side effects. As a Phase 1 trial, this research seeks to understand the drug's effects in humans, offering participants the chance to be among the first to receive this new treatment.
What prior data suggests that 203Pb-RMX-VH-PIB is safe for imaging in humans?
Research has shown that 203Pb-RMX-VH-PIB is under investigation to determine its safety and how it moves through the body. So far, researchers have assessed patient safety using blood tests, vital sign checks, and heart monitoring. These tests help identify any side effects. The study examines the radiation levels received by different organs, which is crucial for understanding safety.
As this study is in its early stages, it primarily focuses on understanding how the treatment works in the body and its safety for people. Detailed safety information might not yet be available, but the trial's emphasis on monitoring demonstrates a careful approach to identifying potential risks.12345Why are researchers excited about this trial?
Researchers are excited about 203Pb-RMX-VH-PIB imaging for brain cancer because it introduces a novel way to visualize tumors. Unlike traditional imaging methods like MRI or CT scans, this treatment uses a radioactive tracer, 203Pb-RMX-VH-PIB, that is injected intravenously and specifically targets cancer cells. This allows for more precise imaging using SPECT/CT scans, potentially providing a clearer picture of the tumor's location and size. By focusing on the biodistribution and radiation dosimetry, this method aims to offer more detailed and accurate information, which could improve treatment planning and outcomes for patients with brain cancer.
What evidence suggests that 203Pb-RMX-VH-PIB imaging is effective for brain cancer?
Research has shown that 203Pb-RMX-VH-PIB may effectively target brain cancer cells. Early studies found that this imaging drug gathers significantly in tumors, which is crucial for successful treatment. This trial will administer 203Pb-RMX-VH-PIB to participants to evaluate its biodistribution and radiation dosimetry. The aim is to understand how the drug moves through the body and the amount of radiation it delivers to different organs. These early results offer hope for improving cancer detection and management.12467
Who Is on the Research Team?
Ebrahim Delpassand, MD, FACNM
Principal Investigator
Radiomedix, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with certain solid tumors, including brain cancers like glioblastoma or pancreatic cancer. Participants must be able to undergo imaging scans and have no conditions that would make the study unsafe for them.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous injection of 203Pb-RMX-VH-PIB and undergo multiple SPECT/CT scans to evaluate biodistribution and dosimetry
Monitoring
Participants are monitored for safety through vital signs, blood exams, and ECGs before and after dosing
Follow-up
Participants are monitored for any side effects for up to 30 days after administration
What Are the Treatments Tested in This Trial?
Interventions
- 203Pb-RMX-VH-PIB
Trial Overview
The study tests a new imaging drug called 203Pb-RMX-VH-PIB, given by IV injection, to see how it spreads in the body and what radiation dose organs receive. Patients will also get several SPECT/CT scans after the injection.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Radiomedix, Inc.
Lead Sponsor
Citations
RadioMedix and Vect-Horus Announce First Patient Dosed ...
In preclinical studies, 203Pb-RMX-VH-PIB demonstrated significant tumor accumulation, a pre-requisite for a successful Targeted Radioligand ...
Phase I Study of 203Pb-RMX-VH-PIB Dosimetry and ...
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 ...
Phase I Study of 203Pb-RMX-VH-PIB Dosimetry and ...
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 ...
4.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/news/first-patient-dosed-in-new-glioblastoma-pancreatic-study/First Patient Dosed in New Glioblastoma/Pancreatic Study
RadioMedix and Vect-Horus have dosed the first patient in an exploratory IND evaluating 203Pb-RMX-VH-PIB, an LDL receptor–targeted SPECT imaging
Precision Population Cancer Medicine in Brain Tumors - PMC
Precision population cancer medicine (PPCM) offers promising avenues for improving outcomes in brain tumor management. This comprehensive review delves into the ...
6.
ctv.veeva.com
ctv.veeva.com/study/phase-i-study-of-203pb-rmx-vh-pib-dosimetry-and-biodistribution-in-patients-with-solid-tumors-like-gPhase I Study of 203Pb-RMX-VH-PIB Dosimetry and ...
203Pb-RMXVH- PIB works in the body and to gather important safety and radiation data
RadioMedix and Vect-Horus Announce First Patient Dosed ...
The objective of this exploratory clinical study is to evaluate the safety, dosimetry, and distribution of 203Pb-RMX-VH-PIB in patients with GBM ...
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