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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
3 to 5 miliCuries of \[203\]Pb administered intravenously 60 minutes before the start of the scans.
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.
The University of Iowa
Iowa City, Iowa, United States
Ability of [203Pb]VMT-α-NET to identify neuroendocrine tumor lesions
percentage of lesions detected with \[203Pb\]VMT-α-NET compared to the gold standard of NetSPOT or Ga-68 DOTATOC.
Time frame: Study days 1 through 5
Measure radiation dose from [203Pb]VMT-α-NET dosimetrically
Determine the radiation absorbed dose to the organs and effective dose by pharmacokinetics through imaging and blood-measurements.
Time frame: Study days 1 through 5
Single-time point survey
Evaluate the potential of feasibility of single-time point imaging to measure the renal radiation dose
Time frame: Study days 1 through 5
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