Status:

RECRUITING

68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.

Lead Sponsor:

Weill Medical College of Cornell University

Collaborating Sponsors:

Novartis Pharmaceuticals

Conditions:

CNS Tumors

Meningioma

Eligibility:

All Genders

18-100 years

Phase:

PHASE4

Brief Summary

The study population consists of patients who undergo resection for somatostatin receptor-positive (SSTR-positive) CNS tumors, focusing on meningioma, and including esthesioneuroblastoma, hemangioblas...

Detailed Description

Prior to the onset of this study, the utility of Ga-68-DOTATATE PET/MRI in meningioma had not been explored. The investigator's pilot study serving as the basis for the proposed protocol resulted in t...

Eligibility Criteria

Inclusion

  • ≥ 18 years of age
  • Diagnosis of meningioma based on pathology reports and suspected recurrence or residual disease based on standard-of-care MRI
  • Additionally, patients with other somatostatin receptor 2 positive brain tumors, including esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain will be considered for the purposes of obtaining feasibility data
  • As the investigator's institution, PET/MRI scanner utilizes a 3 Tesla (T) magnet, patients who may be ineligible to undergo 3T MRI but may undergo 1.5 Tesla (T) MRI, will undergo a 1.5T MRI as per clinical standard-of-care and a Ga68-DOTATATE PET/CT with the PET portion to be fused with the 1.5T MRI utilizing fusion software.

Exclusion

  • Contraindications to gadolinium-based contrast agent
  • History of allergic reaction to Gallium-68-DOTATATE
  • Pregnancy

Key Trial Info

Start Date :

September 4 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2038

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04081701

Start Date

September 4 2019

End Date

December 31 2038

Last Update

November 21 2025

Active Locations (1)

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1

Weill Cornell Medicine

New York, New York, United States, 10065

68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors. | DecenTrialz