Study of 203Pb-RMX-VH-PIB Dosimetry and Biodistribution in Patients With Glioblastoma Multiform (GBM) and Pancreatic Ductal Adenocarcinoma (PDAC)

ConditionsGlioblastoma Multiforme (GBM)Pancreatic Ductal Adenocarcinoma (PDAC)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorRadiomedix, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent.

Subjects aged ≥18 years.

Karnofsky status ≥60.

Negative urine pregnancy test in women of childbearing potential.

Disqualifiers

Known hypersensitivity to RMX-VH peptide analogue, 203Pb-RMX-VH-PIB, 203Pb (Lead) , or any of the excipients of 203Pb-RMX-VH-PIB.

Inability to undergo MRI or CT/SPECT/CT scans

Current somatic or psychiatric disease/condition that may interfere with consent or the objectives and assessments of the study.

Pregnancy or plans to conceive during the course of study participation.

Trial design

Design model

Single group

Treatments tested in this trial

203Pb-RMX-VHPIB injection
Drug
A single intravenous (IV) injection of the investigational radiopharmaceutical 203Pb-RMX-VHPIB administered to eligible patients.
SPECT/CT Imaging
Diagnostic test
Serial whole-body and region-specific SPECT/CT scans performed after IP administration to assess biodistribution and dosimetry

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: 203Pb-RMX-VH-PIB ImagingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Whole-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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radiomedix, Inc.

Lead sponsor

Source ClinicalTrials.gov

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