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

Neuroendocrine Tumor Grade 2 Clinical Trial

Official title:

A Phase 0 First-in-human Clinical Trial of [203Pb]VMT-α-NET SPECT/CT for Somatostatin Receptor Imaging of Neuroendocrine Tumors

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05111509
• Other study ID #: 202006288
• Secondary ID: 5R01CA243014
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: August 22, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a-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.

Related Conditions & MeSH terms

• Neoplasms
• Neuroendocrine Tumor Grade 1
• Neuroendocrine Tumor Grade 2
• Neuroendocrine Tumors

Intervention

Drug:
• [203Pb]VMT-a-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.

Locations

Country	Name	City	State
United States	The University of Iowa	Iowa City	Iowa

Sponsors (4)

Lead Sponsor	Collaborator
Yusuf Menda	Holden Comprehensive Cancer Center, National Cancer Institute (NCI), Perspective Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of [203Pb]VMT-a-NET to identify neuroendocrine tumor lesions	percentage of lesions detected with [203Pb]VMT-a-NET compared to the gold standard of NetSPOT or Ga-68 DOTATOC.	Study days 1 through 5
Secondary	Measure radiation dose from [203Pb]VMT-a-NET dosimetrically	Determine the radiation absorbed dose to the organs and effective dose by pharmacokinetics through imaging and blood-measurements.	Study days 1 through 5
Secondary	Single-time point survey	Evaluate the potential of feasibility of single-time point imaging to measure the renal radiation dose	Study days 1 through 5