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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: Active Phase 2 study of Pheochromocytoma and Paraganglioma, sponsored by Advanced Accelerator Applications.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Absorbed radiation doses in target organ (e.g. kidney and bone marrow) was evaluated when all Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) and Pheochromocytoma and paraganglioma (PPGLs) as a pooled cohort patients had completed the 1st treatment of Lutathera and completed the dosimetry assessment.
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 |
What the registry record for NCT04711135 still lists
NCT04711135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 519-participant average among 14 other Pheochromocytoma trials with a reported enrollment target (98% lower).
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 lists 7 locations in 4 states (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.
Learn More About Clinical Trials
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Where NCT04711135's enrollment target sits among peer trials
11 13th of 14 higher than 2 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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