RecruitingPhase 4NCT04081701

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

68Ga(Gallium)-DOTATATE Positron Emission Tomography (PET)/MRI in the Diagnosis and Management of Somatostatin Receptor Positive Central Nervous System CNS Tumors.


Sponsor

Weill Medical College of Cornell University

Enrollment

200 participants

Start Date

Sep 4, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special type of brain scan — combining PET and MRI — to better detect and manage certain brain tumors that have specific receptors on their surface (called somatostatin receptor-positive tumors). The scan uses a radioactive tracer called 68-Ga DOTATATE to find these tumors more accurately than standard imaging. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with a meningioma (a type of brain tumor) and doctors suspect it has returned or is still present - You have another type of brain tumor that may respond to this tracer, such as pituitary adenoma, paraganglioma, or certain cancers that have spread to the brain **You may NOT be eligible if...** - You are allergic to the contrast dye used in MRI scans (gadolinium-based) - You have had an allergic reaction to the 68-Ga DOTATATE tracer before - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTGa68-DOTATATE-PET/MRI

In patients with meningioma who are undergoing surgical planning, subjects will undergo a PET scan at the time of their pretreatment or preoperative standard of care MRI exam, prior to surgery performed for research purposes. Instead of the standard of care MRI exam, subjects will undergo a dedicated hybrid Gallium-68-DOTATATE PET/MRI.There will be up to two follow-up with Ga68-DOTATATE PET/MRI scans performed as standard of care. In patients with SSTR-positive CNS tumors that are non-meningioma, MRI is often performed to assess extent of disease. Subjects may be asked to undergo a PET scan for research purposes at the time of their standard of care MRI. Instead of the standard of care MRI exam, they may be asked to undergo a dedicated hybrid Gallium-68-DOTATATE PET/MRI.


Locations(1)

Weill Cornell Medicine

New York, New York, United States

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NCT04081701


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