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

Medulloblastoma Clinical Trial

— DOMINO-START  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04081701
• Other study ID #: 1807019445
• Status: Recruiting
• Phase: Phase 4
• Start date: September 4, 2019
• Est. completion date: December 31, 2038

Study information

• Verified date: January 2024
• Source: Weill Medical College of Cornell University
• Contact: Jana Ivanidze, MD/Ph.D
• Phone: 212-746-4587
• Email: jai9018[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

Prior to the onset of this study, the utility of Ga-68-DOTATATE PET/MRI in meningioma had not been explored. The investigator's pilot study serving as the basis for the proposed protocol resulted in the - to the investigators' knowledge - largest case series of 21 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 continued 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2038
• Est. primary completion date: December 31, 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Central Nervous System Neoplasms
• CNS Tumors
• Esthesioneuroblastoma
• Esthesioneuroblastoma, Olfactory
• Hemangioblastoma
• Medulloblastoma
• Meningioma
• Paraganglioma
• Pituitary Adenoma
• Pituitary Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate whether Ga-68-DOTATATE PET/MRI provides additional clinical benefit	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.	Longitudinal assessment up to 10 years
Secondary	Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, SSTR2 expression	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.	Longitudinal assessment up to 10 years
Secondary	Correlate Ga-68-DOTATATE PET/Magnetic Resonance(MR) findings with histopathologic biomarker, Ki67	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.	Longitudinal assessment up to 10 years
Secondary	Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, progesterone receptor	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.	Longitudinal assessment up to 10 years
Secondary	Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, epidermal growth factor receptor (EGFR)	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.	Longitudinal assessment up to 10 years