[Ga68] DOTATATE PET/MRI-guided radiosurgical treatment planning and response assessment in meningiomas.
Jana Ivanidze, Se Jung Chang, Arsalan Haghdel...
https://pubmed.ncbi.nlm.nih.gov/38553990Actively Recruiting
Phase 4
Age: 18Years - 100Years
All Genders
ID04081701
68Ga-DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive Central Nervous System Tumors
Led by Weill Medical College of Cornell University · Updated on 2025-11-21
200
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the use of Gallium-68-DOTATATE PET/MRI in patients with somatostatin receptor-positive (SSTR-positive) central nervous system (CNS) tumors, mainly focusing on meningioma but also including other tumor types such as esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain. The study aims to assess the diagnostic usefulness of this imaging technique, especially in distinguishing tumor recurrence from post-treatment changes, with a particular interest in cases where tumor location limits surgical removal or where patients have higher-grade disease or previous radiation treatment. This is a Phase 4 interventional study sponsored by Weill Medical College of Cornell University.
CONDITIONS
Brief 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
You may qualify if you...
- 18 years of age or older
- Diagnosis of meningioma confirmed by pathology with suspected recurrence or residual disease on standard MRI
- Patients with other somatostatin receptor 2 positive brain tumors such as esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, or SSTR-positive systemic cancers metastatic to the brain
- Ability to undergo 3 Tesla MRI or 1.5 Tesla MRI with PET/CT imaging as per clinical standards
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
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Initial scan plus up to two follow-up scans over standard clinical care duration
Participants undergo Ga-68-DOTATATE PET/MRI scans to assess somatostatin receptor positive CNS tumors, replacing standard MRI exams during surgical planning or disease extent assessment.
1 baseline visit and up to 2 follow-up visits (in-person)
Long-term Monitoring
Duration - Up to 10 years
Participants are followed longitudinally for up to 10 years to evaluate clinical outcomes and correlate PET/MRI findings with histopathologic biomarkers.
Visits scheduled according to clinical follow-up and standard care
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
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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Published Research Related To This Trial
Evaluating diagnostic accuracy and determining optimal diagnostic thresholds of different approaches to [68Ga]-DOTATATE PET/MRI analysis in patients with meningioma.
Sean H Kim, Michelle Roytman, Gabriela Madera...
https://pubmed.ncbi.nlm.nih.gov/35661809Dynamic 68Ga-DOTATATE PET/MRI in the Diagnosis and Management of Intracranial Meningiomas.
Jana Ivanidze, Michelle Roytman, Myrto Skafida...
https://pubmed.ncbi.nlm.nih.gov/35275019