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NCT04081701 · ClinicalTrials.gov registry record · Phase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
A Phase 4 study of Medulloblastoma and Meningioma, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT04081701 is a Phase 4 study of Medulloblastoma and Meningioma that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 200 participants, above the 134-participant average among 29 other Medulloblastoma trials with a reported enrollment target (49% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04081701, a Phase 4 study of Medulloblastoma and Meningioma, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
The study population consists of patients who undergo resection for somatostatin receptor-positive (SSTR-positive) CNS tumors, focusing on meningioma, and including esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain, such as small cell carcinoma of the lung. The study indication is to determine the diagnostic utility of 68Ga-DOTATATE PET/MRI in the diagnosis and management of patients with SSTR-positive CNS tumors, specifically whether 68Ga-DOTATATE PET/MRI demonstrates utility distinguishing between tumor recurrence and post-treatment change. To date, the utility of Ga-68-DOTATATE PET/MRI in meningioma has not been explored. Investigators have over the past 3 months been able to accrue the largest case series of presently 12 patients in whom Ga-68-DOTATATE PET/MRI demonstrated utility in the assessment of meningioma, including assessment for postsurgical/postradiation recurrence, detection of additional lesions not visualized on MRI alone, and evaluation of osseous invasion. Based on this initial experience, investigators intend to study the impact of Ga-68-DOTATATE PET/MRI in the assessment of the extent of residual tumor in patients status post meningioma resection, specifically in patients in whom tumor location limits resectability, patients with World Health Organization (WHO) grade II/III disease, and patients with history of stereotactic radiosurgery (SRS) who develop postradiation change.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Ga68-DOTATATE-PET/MRI
Study Locations (1)
New York
- Weill Cornell Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-09-04 |
| Est. Completion | 2038-12-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04081701
The ClinicalTrials.gov registry entry for NCT04081701 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 134-participant average among 29 other Medulloblastoma trials with a reported enrollment target (49% higher). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Medulloblastoma appearing as the primary indexed condition, and to 1 intervention - of which Ga68-DOTATATE-PET/MRI is the first listed.
NCT04081701 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04081701 about?
NCT04081701 is a clinical study titled "68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.". The study population consists of patients who undergo resection for somatostatin receptor-positive (SSTR-positive) CNS tumors, focusing on meningioma, and including esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastat...
What is the current status of trial NCT04081701?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2019-09-04. Estimated completion is 2038-12-31.
What conditions does trial NCT04081701 study?
This clinical trial studies the following conditions: Medulloblastoma, Meningioma, Paraganglioma, Pituitary Adenoma, Esthesioneuroblastoma.
What interventions are being tested in trial NCT04081701?
The interventions under investigation include: Ga68-DOTATATE-PET/MRI (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04081701?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04081701 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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