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A Safety Study of 212Pb-VMT-alpha-NET in Patients With Neuroendocrine Tumors

NCT06148636 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-11-04

No results posted yet for this study

Summary

This is a safety study to determine the recommended dose to test in clinical trials. The study involves two treatments with 212Pb (212-lead) VMT-α-NET. This is a safety study only; it will most likely not provide therapeutic benefit.

Conditions

  • Neuroendocrine Tumors
  • Neuroendocrine Tumor of the Lung
  • Neuroendocrine Tumor Grade 1
  • Neuroendocrine Tumor Grade 2
  • Neuroendocrine Tumor of Pancreas

Interventions

DRUG

[212Pb] VMT-α-NET

Up to 2 infusions with \[212Pb\] VMT-α-NET, each infusion separated by at least 8 weeks. During each infusion, the participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage.

DIAGNOSTIC_TEST

[203Pb] VMT-α-NET SPECT/CT

The \[203Pb\] VMT-α-NET SPECT/CT is performed for all participants to determine trial eligibility as well as for the calculations to determine the estimated radiation dose to kidneys. This involves three imaging sessions of about 2 hours each over 2 days. The participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage at the time they receive the injection of . \[203Pb\] VMT-α-NET, a radioactive tracer drug.

Sponsors & Collaborators

  • Holden Comprehensive Cancer Center

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Perspective Therapeutics

    collaborator INDUSTRY

  • David Bushnell

    lead OTHER

Principal Investigators

  • David Bushnell, MD · University of Iowa

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06148636 on ClinicalTrials.gov