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
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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