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

Primary Purpose

Neuroendocrine Tumor Grade 2, Neuroendocrine Tumor Grade 1

Status

Enrolling by invitation

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

[203Pb]VMT-α-NET

SPECT/CT

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumor Grade 2 focused on measuring Alpha Particles, Pb-203 radioisotope, Single Photon Emission Computed Tomography Computed Tomography, SPECT CT Scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 [68Ga]DOTATOC or [68Ga]DOTATATE 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:

Women who are pregnant or breast feeding. A pregnancy test will be administered to women of child-bearing potential (per institutional policies) at screening. Women must agree to pregnancy tests prior to each administration of a radionuclidic agent for this study.
Females or males of reproductive potential who decline to use effective contraception through the study (22 days equaling 10 half-lives).
Lactating women 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.

Sites / Locations

The University of Iowa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[203Pb]VMT-α-NET SPECT/CT

Arm Description

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

Outcomes

Primary Outcome Measures

Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions

percentage of lesions detected with [203Pb]VMT-α-NET compared to the gold standard of NetSPOT or Ga-68 DOTATOC.

Secondary Outcome Measures

Measure radiation dose from [203Pb]VMT-α-NET dosimetrically

Determine the radiation absorbed dose to the organs and effective dose by pharmacokinetics through imaging and blood-measurements.

Single-time point survey

Evaluate the potential of feasibility of single-time point imaging to measure the renal radiation dose

Full Information

NCT ID

NCT05111509

First Posted

October 30, 2021

Last Updated

April 17, 2023

Sponsor

Yusuf Menda

Collaborators

Viewpoint Molecular Targeting, Holden Comprehensive Cancer Center, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05111509

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

August 22, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yusuf Menda

Collaborators

Viewpoint Molecular Targeting, Holden Comprehensive Cancer Center, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Tumor Grade 2, Neuroendocrine Tumor Grade 1

Keywords

Alpha Particles, Pb-203 radioisotope, Single Photon Emission Computed Tomography Computed Tomography, SPECT CT Scan

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

[203Pb]VMT-α-NET SPECT/CT

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

[203Pb]VMT-α-NET

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

SPECT/CT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions

Description

percentage of lesions detected with [203Pb]VMT-α-NET compared to the gold standard of NetSPOT or Ga-68 DOTATOC.

Time Frame

Study days 1 through 5

Secondary Outcome Measure Information:

Title

Measure radiation dose from [203Pb]VMT-α-NET dosimetrically

Description

Determine the radiation absorbed dose to the organs and effective dose by pharmacokinetics through imaging and blood-measurements.

Time Frame

Study days 1 through 5

Title

Single-time point survey

Description

Evaluate the potential of feasibility of single-time point imaging to measure the renal radiation dose

Time Frame

Study days 1 through 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yusuf Menda, M.D.

Organizational Affiliation

University of Iowa

Official's Role

Study Chair

Facility Information:

Facility Name

The University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be shared from those patient partners who agree to it. Data will be codified for the investigational team to provided additional details - as necessary - or confirm against source.

IPD Sharing Time Frame

After study completion

IPD Sharing Access Criteria

email the study chair; a non-disclosure and/or data usage agreement will most likely be required.

Learn more about this trial

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

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