Using 68-Ga DOTATATE PET/MRI to Diagnose and Manage Certain Brain Tumors
68Ga(Gallium)-DOTATATE Positron Emission Tomography (PET)/MRI in the Diagnosis and Management of Somatostatin Receptor Positive Central Nervous System CNS Tumors.
This study is testing if a special type of imaging called 68Ga-DOTATATE PET/MRI can help doctors better diagnose and manage certain brain tumors, especially meningiomas, by telling the difference between tumor recurrence and changes after treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04081701 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 68Ga-DOTATATE PET/MRI in diagnosing and managing somatostatin receptor-positive CNS tumors, particularly meningioma. It aims to determine if this imaging technique can accurately distinguish between tumor recurrence and post-treatment changes. The study includes patients who have undergone resection for these tumors and assesses the utility of this method in detecting additional lesions and evaluating residual tumor extent. The research builds on prior findings that suggest this imaging approach may provide significant insights into tumor management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of meningioma or other specified somatostatin receptor-positive brain tumors who are suspected of having recurrent or residual disease.
Not a fit: Patients who are pregnant or have contraindications to gadolinium-based contrast agents or a history of allergic reactions to Gallium-68-DOTATATE may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic accuracy and management strategies for patients with somatostatin receptor-positive CNS tumors.
How similar studies have performed: While the utility of Ga-68-DOTATATE PET/MRI in meningioma has not been extensively studied, preliminary findings suggest promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 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 Criteria: * Contraindications to gadolinium-based contrast agent * History of allergic reaction to Gallium-68-DOTATATE * Pregnancy
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jana Ivanidze, MD/Ph.D — Weill Medical College of Cornell University
- Study coordinator: Jana Ivanidze, MD/Ph.D
- Email: jai9018@med.cornell.edu
- Phone: 212-746-4587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.