Clinical trial NCT05111509: 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
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Neuroendocrine Tumor Grade 2
Neuroendocrine Tumor Grade 1
Keywords: Alpha Particles
Pb-203 radioisotope
Single Photon Emission Computed Tomography Computed Tomography
SPECT CT Scan
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Perspective Therapeutics
name: Holden Comprehensive Cancer Center
name: National Cancer Institute (NCI)
First posted: 2021-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions
timeFrame: Study days 1 through 5
Secondary outcomes:
measure: Measure radiation dose from [203Pb]VMT-α-NET dosimetrically
timeFrame: Study days 1 through 5
measure: Single-time point survey
timeFrame: Study days 1 through 5
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Yusuf Menda, M.D.
role: STUDY_CHAIR
References: