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

Neuroendocrine Tumor Grade 2 Clinical Trial

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

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Neoplasms
• Neuroendocrine Tumor Grade 1
• Neuroendocrine Tumor Grade 2
• Neuroendocrine Tumors

• NCT number: NCT05111509
• Study type: Interventional
• Source: University of Iowa
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: August 22, 2022
• Completion date: December 31, 2025