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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions