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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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-meningiom

Первичные конечные точки

• Evaluate whether Ga-68-DOTATATE PET/MRI provides additional clinical benefit [Срок оценки: Longitudinal assessment up to 10 years]

Вторичные конечные точки (4)

• Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, SSTR2 expression [Срок оценки: Longitudinal assessment up to 10 years]
• Correlate Ga-68-DOTATATE PET/Magnetic Resonance(MR) findings with histopathologic biomarker, Ki67 [Срок оценки: Longitudinal assessment up to 10 years]
• Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, progesterone receptor [Срок оценки: Longitudinal assessment up to 10 years]
• Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, epidermal growth factor receptor (EGFR) [Срок оценки: Longitudinal assessment up to 10 years]

Критерии участия

Критерии включения

• ≥ 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Weill Cornell Medicine — New York

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT04081701 · 1807019445

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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