Sponsor study identifier
Secondary identifiers
NIH
interventional
24
1 country
1
Study Start
November 10, 2023
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a safety study to determine the recommended dose to test in clinical trials. The study involves two treatments with 212Pb (212-lead) VMT-α-NET. This is a safety study only; it will most likely not provide therapeutic benefit.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 10, 2023
Actual (reported)November 20, 2023
Actual (reported)November 28, 2023
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Determine recommended therapeutic dose of [212Pb] VMT-α-NET
Determine the recommended phase 2 dose for therapy with \[212Pb\]VMT-Α-NET administered intravenously to patients with neuroendocrine tumors that have progressed despite therapy.
From study day 1 through 6 months post-treatment
Objective Response Rate (ORR)
At 6 months post-treatment
Maximum tolerated radiation dose for kidneys
From study day 1 through 12 months post treatment
This dose level is used if the starting dose level is deemed to have unacceptable toxicity. Participants are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 200 cGy.
This is the starting dose level for participants. Participants are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 350 cGy.
Up to 2 infusions with \[212Pb\] VMT-α-NET, each infusion separated by at least 8 weeks. During each infusion, the participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage.
Holden Comprehensive Cancer Center at the University of Iowa
Iowa City, Iowa, 52242, United States
David Bushnell, MD
University of Iowa
First Submitted
November 20, 2023
First Posted
November 28, 2023
Study Start
November 10, 2023
Actual (reported)Primary Completion
December 31, 2026
Imaging Properties of PET Radiotracer [18F]3F-PHPG in Patients With Neuroendocrine Tumors
If the participants from Cohort 1 tolerate therapy, new participants are enrolled and are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 600 cGy.
If the participants from Cohort 2 tolerate therapy, new participants are enrolled and are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 810 cGy.
If the participants from Cohort 3 tolerate therapy, new participants are enrolled and are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 1050 cGy.
The \[203Pb\] VMT-α-NET SPECT/CT is performed for all participants to determine trial eligibility as well as for the calculations to determine the estimated radiation dose to kidneys. This involves three imaging sessions of about 2 hours each over 2 days. The participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage at the time they receive the injection of . \[203Pb\] VMT-α-NET, a radioactive tracer drug.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 4, 2025
Record last verified: 2025-11
A HIPAA limited dataset will be shared with requestors for each participant who has provided consent to data sharing. Data will represent critical and / or key data for primary and secondary objectives. Codebook defining data, as well as the protocol, consent, and statistical analysis plan will also be shared.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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