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NCT06427798 · ClinicalTrials.gov registry record · Phase 1
Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR+ Gastrointestinal Neuroendocrine Tumor and Pheochromocytoma/Paraganglioma Previously Treated With Systemic Targeted Radioligand Therapy
A Phase 1 study of Pheochromocytoma and Somatostatin Receptor Positive, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT06427798: Recruiting Phase 1 study of Pheochromocytoma and Somatostatin Receptor Positive, sponsored by National Cancer Institute (NCI).
NCT06427798 is a Phase 1 study of Pheochromocytoma and Somatostatin Receptor Positive that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 66 participants, below the 515-participant average among 14 other Pheochromocytoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06427798, a Phase 1 study of Pheochromocytoma and Somatostatin Receptor Positive, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Gastrointestinal neuroendocrine tumors (GI NET) are a type of cancer that affects the stomach and intestines; pheochromocytoma/paragangliomas (PPGL) are tumors that grow in or near the adrenal glands. Both of these types of tumor have high levels of a protein called somatostatin receptors (SSTR) on their surfaces. Researchers want to test a treatment that targets SSTR. Objective: To test a drug (\[212Pb\]VMT-alpha-NET) in people with GI NET or PPGL. The drug has 2 components: a protein to bind to SSTR and a radioactive agent to kill the cancer cells. Eligibility: Adults aged 18 years or older with GI NET or PPGL tumors that have spread and cannot be removed with surgery. Design: Participants will be screened. They will have a physical exam, with imaging scans, blood tests, and tests of their heart function. \[212Pb\]VMT-alpha-NET is given through a tube attached to a needle inserted into a vein (infusion). Treatment will be given in four 8 week cycles. Participants will receive the drug on the first day of each cycle. They will remain in the clinic at least 4 hours after each infusion and may need to stay in the hospital for up to 48 hour for monitoring and testing. They will have blood tests every week of each cycle. Some participants will also get a related study drug (\[203Pb\]VMT-alpha-NET). They will receive this drug a few days before the first 2 cycles. At 4, 24, and 48 hours after each infusion, they will have whole body scans. These scans will show where the study drug went in their body. Follow-up visits will continue for 10 years....
Primary Outcome
The MTD will be presented as a recommended dose to be used as the recommended phase II dose (RP2D) for the combined participant population, as well as for each disease group being studied (GI-NET, PPGL).
Conditions Studied
Interventions
- DRUG 68Ga-DOTATATE
- DRUG [203Pb]VMT-alpha-NET
- DRUG [212Pb]VMT-alpha-NET
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2025-02-07 |
| Est. Completion | 2039-07-01 |
| Phase | Phase 1 |
What NCT06427798 shows while recruiting
NCT06427798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 515-participant average among 14 other Pheochromocytoma trials with a reported enrollment target (87% lower).
The record links to 4 conditions, with Pheochromocytoma appearing as the primary indexed condition, and to 3 interventions - of which 68Ga-DOTATATE is the first listed.
NCT06427798 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06427798 about?
NCT06427798 is a clinical study titled "Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR+ Gastrointestinal Neuroendocrine Tumor and Pheochromocytoma/Paraganglioma Previously Treated With Systemic Targeted Radioligand Therapy". Background: Gastrointestinal neuroendocrine tumors (GI NET) are a type of cancer that affects the stomach and intestines; pheochromocytoma/paragangliomas (PPGL) are tumors that grow in or near the adrenal glands. Both of these types of tumor have high levels of a protein called somatostatin recepto...
What is the current status of trial NCT06427798?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2025-02-07. Estimated completion is 2039-07-01.
What conditions does trial NCT06427798 study?
This clinical trial studies the following conditions: Pheochromocytoma, Somatostatin Receptor Positive, Gastrointestinal Neuroendocrine Tumors, Paragangliomas.
What interventions are being tested in trial NCT06427798?
The interventions under investigation include: 68Ga-DOTATATE (DRUG), [203Pb]VMT-alpha-NET (DRUG), [212Pb]VMT-alpha-NET (DRUG).
Who is sponsoring clinical trial NCT06427798?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06427798 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06427798's enrollment target sits among peer trials
66 8th of 14 higher than 7 of 14 other Pheochromocytoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pheochromocytoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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