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NCT04711135 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs
A Phase 2 study of Pheochromocytoma and Paraganglioma, sponsored by Advanced Accelerator Applications.
- Active
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
- 7
- Study locations
NCT04711135 is a Phase 2 study of Pheochromocytoma and Paraganglioma that is active but no longer recruiting, run by Advanced Accelerator Applications. The registered enrollment target is 11 participants, below the 519-participant average among 14 other Pheochromocytoma trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 4 states.
The verdict
NCT04711135, a Phase 2 study of Pheochromocytoma and Paraganglioma, is active but no longer recruiting, sponsored by Advanced Accelerator Applications.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to \<18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort.
Conditions Studied
Interventions
- DRUG Lutetium [177Lu] oxodotreotide/dotatate
Study Locations (7)
Other
- Centre Léon Berard - Lyon
- Maria Sklodowska-Curie National Research Institute of Oncology - Gliwice
- Hospital Universitari Vall d'Hebron - Barcelona
- University College Hospital of London - London
Kentucky
- University of Kentucky - Lexington
Ohio
- Cincinnati Children's Hospital - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2034-02-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04711135
The ClinicalTrials.gov registry entry for NCT04711135 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 519-participant average among 14 other Pheochromocytoma trials with a reported enrollment target (98% lower). The listed sponsor is Advanced Accelerator Applications, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Pheochromocytoma appearing as the primary indexed condition, and to 1 intervention - of which Lutetium [177Lu] oxodotreotide/dotatate is the first listed.
NCT04711135 reports 7 study locations spanning 4 distinct geographic areas - top geographies include Other, Kentucky, Ohio.
Frequently Asked Questions
What is clinical trial NCT04711135 about?
NCT04711135 is a clinical study titled "Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs". This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to \<18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL ...
What is the current status of trial NCT04711135?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2022-08-31. Estimated completion is 2034-02-06.
What conditions does trial NCT04711135 study?
This clinical trial studies the following conditions: Pheochromocytoma, Paraganglioma, Gastroenteropancreatic Neuroendocrine Tumors.
What interventions are being tested in trial NCT04711135?
The interventions under investigation include: Lutetium [177Lu] oxodotreotide/dotatate (DRUG).
Who is sponsoring clinical trial NCT04711135?
This trial is sponsored by Advanced Accelerator Applications, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04711135 being conducted?
This trial has 7 study locations across Kentucky, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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