A First-in-human Clinical Trial to Evaluate an Alpha-radiation Imaging Agent (NCT05111509) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
A First-in-human Clinical Trial to Evaluate an Alpha-radiation Imaging Agent
United States20 participantsStarted 2022-08-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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).
* La…
What they're measuring
1
Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions