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Trial record 3 of 9 for:    "Paragangliomas 1" | "Somatostatin"

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

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ClinicalTrials.gov Identifier: NCT04081701
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
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.

Condition or disease Intervention/treatment
CNS Tumors Meningioma Esthesioneuroblastoma Hemangioblastoma Medulloblastoma Paraganglioma Pituitary Adenoma Diagnostic Test: Ga68-DOTATATE-PET/MRI

Detailed Description:
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 WHO grade II/III disease, and patients with history of SRS who develop postradiation change.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 68Ga(Gallium)-DOTATATE Positron Emission Tomography (PET)/MRI in the Diagnosis and Management of Somatostatin Receptor Positive Central Nervous System CNS Tumors.
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021


Group/Cohort Intervention/treatment
Meningioma
Cohort of 30 subjects with meningioma.
Diagnostic Test: 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-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.


Non-Meningioma

Cohort of 60 subjects with non-meningioma:

(esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma and SSTR-positive tumors metastatic to the brain)

Diagnostic Test: 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-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.





Primary Outcome Measures :
  1. Evaluate whether Ga-68-DOTATATE PET/MRI provides additional clinical benefit [ Time Frame: Longitudinal assessment up to 2 years ]
    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.


Secondary Outcome Measures :
  1. Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, SSTR2 expression [ Time Frame: Longitudinal assessment up to 2 years ]
    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.

  2. Correlate Ga-68-DOTATATE PET/Magnetic Resonance(MR) findings with histopathologic biomarker, Ki67 [ Time Frame: Longitudinal assessment up to 2 years ]
    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.

  3. Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, progesterone receptor [ Time Frame: Longitudinal assessment up to 2 years ]
    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.

  4. Correlate Ga-68-DOTATATE PET/MR findings with histopathologic biomarker, epidermal growth factor receptor (EGFR) [ Time Frame: Longitudinal assessment up to 2 years ]
    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.


Biospecimen Retention:   Samples Without DNA
Molecular biomarkers will be assessed including SSTR2, Ki-67, EGFR expression, and progesterone receptor expression.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient cohort will consist of individuals who undergo resection for SSTR-positive CNS tumors, including meningioma, esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive tumors metastatic to the brain, and in whom tumor recurrence versus post treatment change is questioned for reasons including, but not limited to, high WHO grade, suspected subtotal resection based on tumor location, or positive surgical margins. Subjects with diagnosis of meningioma specifically in patients in whom tumor location limits gross total resectability (for example in the skullbase, sphenoid wing, spheno-orbital location) and patients who have WHO grade II/ III disease.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04081701


Contacts
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Contact: Jana Ivanidze, MD/Ph.D 212-746-4587 jai9018@med.cornell.edu

Locations
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United States, New York
Jana Ivanidze Recruiting
New York, New York, United States, 10065
Contact: Jana Ivanidze, MD/Ph.D    212-746-4587    jai9018@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Jana Ivanidze, MD/Ph.D Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04081701     History of Changes
Other Study ID Numbers: 1807019445
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Paraganglioma
Somatostatin
Adenoma
Meningioma
Medulloblastoma
Esthesioneuroblastoma, Olfactory
Pituitary Neoplasms
Central Nervous System Neoplasms
Hemangioblastoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroectodermal Tumors, Primitive
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral