68-Ga DOTATATE PET/MRI for CNS Tumors

This study is exploring whether a special type of scan, called 68-Ga DOTATATE PET/MRI, can help doctors better diagnose and manage certain brain tumors. These tumors include meningioma, esthesioneuroblastoma, hemangioblastoma, and medulloblastoma, among others, that are "somatostatin receptor positive" (meaning they have specific markers on their cells). Researchers want to see if this scan can provide more useful information than standard MRI, especially in telling the difference between a tumor growing back and changes from previous treatments. You might be able to join if you are 18 to 100 years old and have a diagnosis of meningioma with suspected recurrence, or another somatostatin receptor positive brain tumor. The study aims to evaluate the clinical benefit of this scan over a long period, up to 10 years. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 200 participants. It is not specified if it is randomized or blinded.
What's involved
If you have meningioma and are having surgery, you would undergo a PET scan at the same time as your standard MRI before surgery. The study also involves longitudinal assessment for up to 10 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed with longitudinal assessment for up to 10 years to evaluate clinical benefit.

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NCT04081701

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

Recruiting
PHASE4Ages 18+InterventionalDiagnostic
Weill Medical College of Cornell University
~200 participants
Updated 2025-11-21 on ClinicalTrials.gov
What's tested:Ga68-DOTATATE-PET/MRI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate whether Ga-68-DOTATATE PET/MRI provides additional clinical benefit
Measured over Longitudinal assessment up to 10 years
CNS Tumors
Meningioma
Esthesioneuroblastoma
Hemangioblastoma
Medulloblastoma
Paraganglioma
Pituitary Adenoma
1 sites across 1 states
New York1
  • Jana Ivanidze, MD/Ph.D · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

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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
  • Evaluate whether Ga-68-DOTATATE PET/MRI provides additional clinical benefitLongitudinal assessment up to 10 years

    Diagnostic accuracy of Ga-68-DOTATATE PET/MRI will be compared to MRI alone. Correlative analyses will be performed including logistic regression/ Spearman correlation for continuous variables, and Mann-Whitney U tests for not normally distributed subgroups for variables allowing for dichotomization.