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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meningioma | Other | Cohort of 30 subjects with meningioma. |
|
| Non-Meningioma | Other | Cohort of 60 subjects with non-meningioma: (esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma and SSTR-positive tumors metastatic to the brain) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jana Ivanidze, MD/Ph.D | Contact | 212-746-4587 | jai9018@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jana Ivanidze, MD/Ph.D | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38553990 | Derived | 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. | |
| 35661809 |
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|
| Longitudinal assessment up to 10 years |
| 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 |
| 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 |
| 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 |
| 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. |
| 35275019 | 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. |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D008579 | Meningioma |
| D018304 | Esthesioneuroblastoma, Olfactory |
| D018325 | Hemangioblastoma |
| D008527 | Medulloblastoma |
| D010235 | Paraganglioma |
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D009447 | Neuroblastoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D020431 | Olfactory Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D018324 | Hemangioma, Capillary |
| D006391 | Hemangioma |
| D005910 | Glioma |
| D018358 | Neuroendocrine Tumors |
| D004701 | Endocrine Gland Neoplasms |
| D007029 | Hypothalamic Neoplasms |
| D015173 | Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
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