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

NCT05111509 | Active Not Recruiting Early Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: 2020062885R01CA243014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroendocrine Tumor Grade 2; Neuroendocrine Tumor Grade 1

Keywords

Alpha Particles; Pb-203 radioisotope; Single Photon Emission Computed Tomography Computed Tomography; SPECT CT Scan

Outcome Measures

Primary Outcomes (1)

• Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions

  percentage of lesions detected with \[203Pb\]VMT-α-NET compared to the gold standard of NetSPOT or Ga-68 DOTATOC.

  Study days 1 through 5

Secondary Outcomes (2)

• Measure radiation dose from [203Pb]VMT-α-NET dosimetrically

  Study days 1 through 5

• Single-time point survey

  Study days 1 through 5

Study Arms (1)

[203Pb]VMT-α-NET SPECT/CT

EXPERIMENTAL

injection of \[203Pb\]VMT-α-NET with serialized imaging and dosimetry measurements

Drug: [203Pb]VMT-α-NET; Device: SPECT/CT

Interventions

[203Pb]VMT-α-NET DRUG

3 to 5 miliCuries of \[203\]Pb administered intravenously 60 minutes before the start of the scans.

[203Pb]VMT-α-NET SPECT/CT

SPECT/CT DEVICE

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.

[203Pb]VMT-α-NET SPECT/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to provide informed consent
• Stated willingness to comply with all study procedures and availability for duration of study
• Aged ≥ 18 years at the time of study drug administration
• Pathologically confirmed (histology or cytology) well-differentiated neuroendocrine tumor (WHO Grade 1 or 2) with primary location known or believed to be midgut or foregut
• At least 1 somatostatin receptor positive tumor site as demonstrated by PET/CT study utilizing an FDA approved PET agent within 12 months of consent
• ≥1 evaluable site of disease measuring ≥ 2.0 cm in any dimension on CT or MRI
• Adequate performance status (ECOG of 0 or 1; or KPS of ≥70).
• Not experiencing an uncontrolled intercurrent illness such as: infection requiring inpatient admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members.

You may not qualify if:

• Individuals who are pregnant or breast feeding. A pregnancy test will be administered to individuals of child-bearing potential (per institutional policies) at screening. Individuals must agree to pregnancy tests prior to each administration of a radionuclidic agent for this study.
• Individuals of reproductive potential who decline to use effective contraception through the study (22 days equaling 10 half-lives).
• Lactating individuals who decline to withhold breastfeeding their child. As the effects of \[203Pb\]VMT-α-NET on the infant are unknown and relatively long half-life, women may not resume breast feeding for the current child.
• Therapeutic investigational drug within 4 weeks of C1D1
• Patients for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk.
• Subject's weight exceeds the limit of the imaging system.
• Long-acting somatostatin analogue treatment ≤ 20 days of C1D1
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to \[90Y\]DOTA-tyr3-Octreotide, Octreoscan®, or \[68Ga\]Octreotide.

Sponsors & Collaborators

• Yusuf Menda: lead
• Perspective Therapeutics: collaborator
• Holden Comprehensive Cancer Center: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Single Photon Emission Computed Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-Photon; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Yusuf Menda, M.D.

  University of Iowa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Director, Nuclear Medicine

Study Record Dates

• First Submitted: October 30, 2021
• First Posted: November 8, 2021
• Study Start: August 22, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After study completion
• Access Criteria: email the study chair; a non-disclosure and/or data usage agreement will most likely be required.

Locations

US (1)