Scan Tests a Dye-Based PET/MRI Imaging Method for Brain and Nerve Tumors
Tests a special PET/MRI scan in adults with somatostatin receptor-positive brain tumors after surgery.
Key facts
- Who runs it
- Weill Medical College of Cornell University
- Where
- New York, United StatesSee the site
- Trial code
- Registry title
- 68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 200 people, planned
- Started
- 4 Sept 2019
- Expected to end
- 31 Dec 2038
- Type of study
- Interventional, 2 groups
- Treatments tested
- Ga68-DOTATATE-PET/MRI
- Record updated
- 30 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a meningioma, whose MRI suggests the tumor came back or was not fully removed. Some other brain tumors that carry somatostatin receptors can also be included.
- Age
- 18 Years to 100 Years
- Sex
- All sexes can join.
- Disease stage
- Meningioma confirmed by pathology report, with suspected recurrence or residual disease on a standard MRI. Other somatostatin receptor 2 positive brain tumors (esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, SSTR-positive cancers spread to the brain) are considered for feasibility data.
- Biomarker or test result
- For the other brain tumors, somatostatin receptor 2 positive (SSTR-positive).
Main reasons for not taking part
- Cannot receive gadolinium-based contrast agent
- Past allergic reaction to Gallium-68-DOTATATE
- Pregnancy
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- ≥ 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
Who cannot take part
- History of allergic reaction to Gallium-68-DOTATATE
- Contraindications to gadolinium-based contrast agent
- Pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Where in United States
- Weill Cornell MedicineNew York, United StatesContact: Jana Ivanidze, MD/Ph.DTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- MeningiomaOther group
Cohort of 30 subjects with meningioma.
Treatment: Ga68-DOTATATE-PET/MRI
- Non-MeningiomaOther group
Cohort of 60 subjects with non-meningioma: (esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma and SSTR-positive tumors metastatic to the brain)
Treatment: Ga68-DOTATATE-PET/MRI
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 68Ga(Gallium)-DOTATATE Positron Emission Tomography (PET)/MRI in the Diagnosis and Management of Somatostatin Receptor Positive Central Nervous System CNS Tumors.
- Plain-language title
- Scan Tests a Dye-Based PET/MRI Imaging Method for Brain and Nerve TumorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04081701, who can take part
- Publications
- Record updated
- 30 October 2026