NCT05111509

A First-in-human Clinical Trial to Evaluate an Alpha-radiation Imaging Agent

A Phase 0 First-in-human Clinical Trial of [203Pb]VMT-α-NET SPECT/CT for Somatostatin Receptor Imaging of Neuroendocrine Tumors

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Yusuf Menda · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first in man study to determine if \[203Pb\]VMT-α-NET identifies neuroendocrine tumors with SPECT/CT. This is the first step to testing \[212Pb\]-based alpha radiation therapy in neuroendocrine therapy.

Detailed description

The goal of this work is to use \[203Pb\]VMT-α-NET as the imaging agent to create a specialized patient treatment plan using \[212Pb\]VMT-α-NET as a first-in-human therapy for treatment resistant or refractory neuroendocrine tumors of the foregut or midgut. The first step is to test the imaging agent \[203Pb\]VMT-α-NET. This requires a very small dose of the drug (microdose) which is then measured by a series of images (like CT scans) over 4 days. Blood samples are also drawn that that time. It is hoped the imaging will identify the tumors so that a therapy using \[212Pb\]VMT-α-NET can be created.

Conditions

• Neuroendocrine Tumor Grade 2
• Neuroendocrine Tumor Grade 1

Interventions

Type	Name	Description
DRUG	[203Pb]VMT-α-NET	3 to 5 miliCuries of \[203\]Pb administered intravenously 60 minutes before the start of the scans.
DEVICE	SPECT/CT	Scans are administered over 3 days: 1 hour post injection, 4 to 8 hours post-injection, 24 to 30 hours post-injection, and 42 to 52 hours post-injection.

Timeline

• Start date: 2022-08-22
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2021-11-08
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study