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

NCT ID: NCT05111509

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2026-06-30

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.

Detailed 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.

Conditions

Neuroendocrine Tumor Grade 2; Neuroendocrine Tumor Grade 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[203Pb]VMT-α-NET SPECT/CT

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

Group Type: EXPERIMENTAL

[203Pb]VMT-α-NET

Intervention Type: DRUG

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

SPECT/CT

Intervention Type: 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.

Interventions

[203Pb]VMT-α-NET

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

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Perspective Therapeutics

INDUSTRY

Sponsor Role: collaborator

Holden Comprehensive Cancer Center

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Yusuf Menda

OTHER

Sponsor Role: lead

Responsible Party

Yusuf Menda

Professor and Director, Nuclear Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yusuf Menda, M.D.

Role: STUDY_CHAIR

University of Iowa

Locations

The University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

5R01CA243014

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202006288

Identifier Type: -

Identifier Source: org_study_id