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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04081701

Collaborator

Novartis Pharmaceuticals (Industry)

Enrollment

Location

36.9

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
CNS Tumors Meningioma Esthesioneuroblastoma Hemangioblastoma Medulloblastoma Paraganglioma Pituitary Adenoma	Diagnostic Test: Ga68-DOTATATE-PET/MRI

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 4, 2019

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Meningioma Cohort of 30 subjects with meningioma.	Diagnostic Test: Ga68-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.
Non-Meningioma Cohort of 60 subjects with non-meningioma: (esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma and SSTR-positive tumors metastatic to the brain)	Diagnostic Test: Ga68-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.

Arm

Intervention/Treatment

Meningioma

Cohort of 30 subjects with meningioma.

Diagnostic Test: Ga68-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.

Non-Meningioma

Cohort of 60 subjects with non-meningioma: (esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma and SSTR-positive tumors metastatic to the brain)

Diagnostic Test: Ga68-DOTATATE-PET/MRI

Outcome Measures

Primary Outcome Measures

Evaluate whether Ga-68-DOTATATE PET/MRI provides additional clinical benefit [Longitudinal assessment up to 2 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.

Secondary Outcome Measures

Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, SSTR2 expression [Longitudinal assessment up to 2 years]
Histopathologic biomarkers, including SSTR2 expression will be assessed for patients with meningioma, who undergo resection. 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.
Correlate Ga-68-DOTATATE PET/Magnetic Resonance(MR) findings with histopathologic biomarker, Ki67 [Longitudinal assessment up to 2 years]
Histopathologic biomarkers, including Ki67 will be assessed for patients with meningioma, who undergo resection. 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.
Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, progesterone receptor [Longitudinal assessment up to 2 years]
Histopathologic biomarkers, including progesterone receptor will be assessed for patients with meningioma, who undergo resection. 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.
Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, epidermal growth factor receptor (EGFR) [Longitudinal assessment up to 2 years]
Histopathologic biomarkers, including EGFR will be assessed for patients with meningioma, who undergo resection. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.