Clinical trial · Interventional
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
68Ga(Gallium)-DOTATATE Positron Emission Tomography (PET)/MRI in the Diagnosis and Management of Somatostatin Receptor Positive Central Nervous System CNS Tumors.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CNS Tumors | Central Nervous System Neoplasm | ALIAS | 0.90 |
| Esthesioneuroblastoma | Olfactory Neuroblastoma | ALIAS | 0.90 |
| Hemangioblastoma | Hemangioblastoma | ONTOLOGY_EXACT | 0.98 |
| Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
| Paraganglioma | Paraganglioma | ONTOLOGY_EXACT | 0.98 |
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ga68-DOTATATE-PET/MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Meningioma
- description
- Cohort of 30 subjects with meningioma.
- interventionNames
- Diagnostic Test: Ga68-DOTATATE-PET/MRI
- type
- OTHER
- label
- Non-Meningioma
- description
- Cohort of 60 subjects with non-meningioma: (esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma and SSTR-positive tumors metastatic to the brain)
- interventionNames
- Diagnostic Test: Ga68-DOTATATE-PET/MRI
Primary outcomes (1)
- measure
- Evaluate whether Ga-68-DOTATATE PET/MRI provides additional clinical benefit
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDIvanidze 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
- DERIVEDKim 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
- DERIVEDIvanidze 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