Neuroendocrine Tumor Grade 2, Neuroendocrine Tumor Grade 1
Conditions
Keywords
Alpha Particles, Pb-203 radioisotope, Single Photon Emission Computed Tomography Computed Tomography, SPECT CT Scan
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.
Interventions
DRUG[203Pb]VMT-α-NET
3 to 5 miliCuries of \[203\]Pb administered intravenously 60 minutes before the start of the scans.
DEVICESPECT/CT
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.
Sponsors
Perspective Therapeutics
Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
Yusuf Menda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed