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

NCT05111509 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Perspective Therapeutics

    collaborator INDUSTRY
  • Holden Comprehensive Cancer Center

    collaborator OTHER
  • National Cancer Institute (NCI)

    collaborator NIH
  • Yusuf Menda

    lead OTHER

Principal Investigators

  • Yusuf Menda, M.D. · University of Iowa

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2026-04-30
Completion
2026-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05111509 on ClinicalTrials.gov