A First-in-human Clinical Trial to Evaluate an Alpha-radiation Imaging Agent
- Conditions
- Neuroendocrine Tumor Grade 2Neuroendocrine Tumor Grade 1
- Interventions
- Device: SPECT/CT
- Registration Number
- NCT05111509
- Lead Sponsor
- Yusuf Menda
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [203Pb]VMT-α-NET SPECT/CT [203Pb]VMT-α-NET injection of \[203Pb\]VMT-α-NET with serialized imaging and dosimetry measurements [203Pb]VMT-α-NET SPECT/CT SPECT/CT injection of \[203Pb\]VMT-α-NET with serialized imaging and dosimetry measurements
- Primary Outcome Measures
Name Time Method Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions Study days 1 through 5 percentage of lesions detected with \[203Pb\]VMT-α-NET compared to the gold standard of NetSPOT or Ga-68 DOTATOC.
- Secondary Outcome Measures
Name Time Method Measure radiation dose from [203Pb]VMT-α-NET dosimetrically Study days 1 through 5 Determine the radiation absorbed dose to the organs and effective dose by pharmacokinetics through imaging and blood-measurements.
Single-time point survey Study days 1 through 5 Evaluate the potential of feasibility of single-time point imaging to measure the renal radiation dose
Trial Locations
- Locations (1)
The University of Iowa
🇺🇸Iowa City, Iowa, United States