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

NCT04081701 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1807019445
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

CNS Tumors; Meningioma; Esthesioneuroblastoma; Hemangioblastoma; Medulloblastoma; Paraganglioma; Pituitary Adenoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, SSTR2 expression

  Longitudinal assessment up to 10 years

• Correlate Ga-68-DOTATATE PET/Magnetic Resonance(MR) findings with histopathologic biomarker, Ki67

  Longitudinal assessment up to 10 years

• Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, progesterone receptor

  Longitudinal assessment up to 10 years

• Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, epidermal growth factor receptor (EGFR)

  Longitudinal assessment up to 10 years

Study Arms (2)

Meningioma

OTHER

Cohort of 30 subjects with meningioma.

Diagnostic Test: Ga68-DOTATATE-PET/MRI

Non-Meningioma

OTHER

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

Interventions

Ga68-DOTATATE-PET/MRI DIAGNOSTIC_TEST

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.

Meningioma; Non-Meningioma

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• Contraindications to gadolinium-based contrast agent
• History of allergic reaction to Gallium-68-DOTATATE
• Pregnancy

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Related Publications (3)

• Ivanidze J, Chang SJ, Haghdel A, Kim JT, Roy Choudhury A, Wu A, Ramakrishna R, Schwartz TH, Cisse B, Stieg P, Muller L, Osborne JR, Magge RS, Karakatsanis NA, Roytman M, Lin E, Pannullo SC, Palmer JD, Knisely JPS. [Ga68] DOTATATE PET/MRI-guided radiosurgical treatment planning and response assessment in meningiomas. Neuro Oncol. 2024 Aug 5;26(8):1526-1535. doi: 10.1093/neuonc/noae067.

  PMID: 38553990 DERIVED

• Kim SH, Roytman M, Madera G, Magge RS, Liechty B, Ramakrishna R, Pannullo SC, Schwartz TH, Karakatsanis NA, Osborne JR, Lin E, Knisely JPS, Ivanidze J. Evaluating diagnostic accuracy and determining optimal diagnostic thresholds of different approaches to [68Ga]-DOTATATE PET/MRI analysis in patients with meningioma. Sci Rep. 2022 Jun 3;12(1):9256. doi: 10.1038/s41598-022-13467-9.

  PMID: 35661809 DERIVED

• Ivanidze J, Roytman M, Skafida M, Kim S, Glynn S, Osborne JR, Pannullo SC, Nehmeh S, Ramakrishna R, Schwartz TH, Knisely JPS, Lin E, Karakatsanis NA. Dynamic 68Ga-DOTATATE PET/MRI in the Diagnosis and Management of Intracranial Meningiomas. Radiol Imaging Cancer. 2022 Mar;4(2):e210067. doi: 10.1148/rycan.210067.

  PMID: 35275019 DERIVED

MeSH Terms

Conditions

Central Nervous System Neoplasms; Meningioma; Esthesioneuroblastoma, Olfactory; Hemangioblastoma; Medulloblastoma; Paraganglioma; Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Neuroblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Olfactory Nerve Diseases; Cranial Nerve Diseases; Hemangioma, Capillary; Hemangioma; Glioma; Neuroendocrine Tumors; Endocrine Gland Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Jana Ivanidze, MD/Ph.D

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana Ivanidze, MD/Ph.D

CONTACT

212-746-4587; jai9018@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 9, 2019
• Study Start: September 4, 2019
• Primary Completion (Estimated): December 31, 2038
• Study Completion (Estimated): December 31, 2038
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)