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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    90
  • sponsor
    Weill Medical College of Cornell University
Updated on 10 October 2021
cancer
pituitary
meningioma
carcinoma
somatostatin
MRI
residual tumor
MRI Scan
paraganglioma
dotatate
brain tumor
stereotactic radiosurgery
recurrent tumor
medulloblastoma
positron emission tomography/computed tomography
3t mri
tumor recurrence
central nervous system tumor
pituitary adenoma
68ga-dotatoc
cancers metastatic
hemangioblastoma
small cell carcinoma of the lung

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.

Description

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 WHO grade II/III disease, and patients with history of SRS who develop postradiation change.

Details
Condition Pituitary Disease, Paraganglioma, paragangliomas, Medulloblastoma, cns neoplasm, Central Nervous System Neoplasms, cns tumors, Hemangioblastoma, Gliomas, cns tumor, Malignant Pheochromocytoma/Paraganglioma, Glioma, central nervous system tumors, central nervous system tumor, Meningiomas, Esthesioneuroblastoma, Pituitary Adenoma, Meningioma, Pituitary Disorders, Neuroblastoma
Treatment Ga68-DOTATATE-PET/MRI
Clinical Study IdentifierNCT04081701
SponsorWeill Medical College of Cornell University
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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