Actively Recruiting

Phase 4
Age: 18Years - 100Years
All Genders
NCT04081701

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

Led by Weill Medical College of Cornell University · Updated on 2025-11-21

200

Participants Needed

1

Research Sites

1008 weeks

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

N

Novartis Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Diagnosis of meningioma based on pathology and suspected recurrence or residual disease on standard MRI
  • Patients with other somatostatin receptor 2 positive brain tumors including esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic brain metastases may be included for feasibility data
  • Patients who cannot undergo 3 Tesla MRI but can undergo 1.5 Tesla MRI will receive 1.5T MRI with Ga68-DOTATATE PET/CT fused imaging as standard care
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Weill Cornell Medicine

New York, New York, United States, 10065

Actively Recruiting

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Research Team

J

Jana Ivanidze, MD/Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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