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

Study acronym: DOMINO-START
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. 2 versions Re-verified since Dec 18, 2024, no change to tracked fieldsv9-v10
  2. Phase: Not specified to Phase 4v8
  3. Enrollment target: 98 to 200
    • Primary and study completion dates: Dec 30, 2022 to Dec 31, 2038
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 13 words
    v7
  4. Enrollment target: 90 to 98
    • Primary and study completion dates: Sep 30, 2022 to Dec 30, 2022
    • Study site revised
    v6
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary and study completion dates: Aug 30, 2021 to Sep 30, 2022v4
  2. Collaborators expanded, about 2 wordsv3
  3. Secondary endpoints revised (4)
    • Eligibility criteria expanded, about 4 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04081701
Lead Sponsor Weill Medical College of Cornell University
Collaborators: Novartis Pharmaceuticals
Conditions
(from sponsor)		 CNS Tumors, Meningioma, Esthesioneuroblastoma, Hemangioblastoma, Medulloblastoma, Paraganglioma, Pituitary Adenoma
Related terms Central Nervous System Neoplasms, Esthesioneuroblastoma, Olfactory, Hemangioblastoma, Medulloblastoma, Meningioma, Paraganglioma, Pituitary Neoplasms
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov