Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 9:27 PM
Study NCT ID:
NCT02518061
Status:
COMPLETED
Last Update Posted:
2020-10-01
First Post:
2015-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
11C-Methionine PET as Prognostic Marker of Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Tumor surgical specimen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-29', 'studyFirstSubmitDate': '2015-08-05', 'studyFirstSubmitQcDate': '2015-08-05', 'lastUpdatePostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of SUVmax (Maximal Standardized Uptake Value) in patients with glioma undergoing surgery with IDH1 mutation, MGMT promoter methylation and 1p/19q co-deletion,', 'timeFrame': 'Baseline SUVmax up to 1 month before surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glioma; 11C-Methionine PET'], 'conditions': ['Glioma']}, 'referencesModule': {'references': [{'pmid': '25520293', 'type': 'BACKGROUND', 'citation': 'Lopci E, Franzese C, Grimaldi M, Zucali PA, Navarria P, Simonelli M, Bello L, Scorsetti M, Chiti A. Imaging biomarkers in primary brain tumours. Eur J Nucl Med Mol Imaging. 2015 Apr;42(4):597-612. doi: 10.1007/s00259-014-2971-8. Epub 2014 Dec 18.'}, {'pmid': '25688497', 'type': 'BACKGROUND', 'citation': 'Schinkelshoek M, Lopci E, Clerici E, Alongi F, Mancosu P, Rodari M, Navarria P, van der Hiel B, Scorsetti M, Chiti A. Impact of 11C-methionine positron emission tomography/computed tomography on radiation therapy planning and prognosis in patients with primary brain tumors. Tumori. 2014 Nov-Dec;100(6):636-44. doi: 10.1700/1778.19268.'}, {'pmid': '25308182', 'type': 'BACKGROUND', 'citation': 'Navarria P, Reggiori G, Pessina F, Ascolese AM, Tomatis S, Mancosu P, Lobefalo F, Clerici E, Lopci E, Bizzi A, Grimaldi M, Chiti A, Simonelli M, Santoro A, Bello L, Scorsetti M. Investigation on the role of integrated PET/MRI for target volume definition and radiotherapy planning in patients with high grade glioma. Radiother Oncol. 2014 Sep;112(3):425-9. doi: 10.1016/j.radonc.2014.09.004. Epub 2014 Oct 9.'}, {'pmid': '30797926', 'type': 'BACKGROUND', 'citation': 'Riva M, Lopci E, Castellano A, Olivari L, Gallucci M, Pessina F, Fernandes B, Simonelli M, Navarria P, Grimaldi M, Ruda R, Castello A, Rossi M, Alfiero T, Soffietti R, Chiti A, Bello L. Lower Grade Gliomas: Relationships Between Metabolic and Structural Imaging with Grading and Molecular Factors. World Neurosurg. 2019 Jun;126:e270-e280. doi: 10.1016/j.wneu.2019.02.031. Epub 2019 Feb 22.'}, {'pmid': '28110346', 'type': 'BACKGROUND', 'citation': 'Lopci E, Riva M, Olivari L, Raneri F, Soffietti R, Piccardo A, Bizzi A, Navarria P, Ascolese AM, Ruda R, Fernandes B, Pessina F, Grimaldi M, Simonelli M, Rossi M, Alfieri T, Zucali PA, Scorsetti M, Bello L, Chiti A. Prognostic value of molecular and imaging biomarkers in patients with supratentorial glioma. Eur J Nucl Med Mol Imaging. 2017 Jul;44(7):1155-1164. doi: 10.1007/s00259-017-3618-3. Epub 2017 Jan 21.'}, {'pmid': '32371671', 'type': 'BACKGROUND', 'citation': 'Castello A, Riva M, Fernandes B, Bello L, Lopci E. The role of 11C-methionine PET in patients with negative diffusion-weighted magnetic resonance imaging: correlation with histology and molecular biomarkers in operated gliomas. Nucl Med Commun. 2020 Jul;41(7):696-705. doi: 10.1097/MNM.0000000000001202.'}, {'pmid': '25812023', 'type': 'BACKGROUND', 'citation': 'Riva M, Rodriguez Y Baena R, Pessina F, Lopci E, Fernandes B, Galli C, Rossi M, Bello L. The diffusion-weighted imaging and 11-C-methionine positron emission tomography depiction of an endodermal cyst at the cervico-medullary junction. Br J Neurosurg. 2015;29(5):739-41. doi: 10.3109/02688697.2015.1023780. Epub 2015 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'This is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 145 patients with glioma treated with surgery with radical intent at our center.', 'detailedDescription': 'This is a retrospective observation that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of 145 patients with glioma treated with surgery with radical intent at our center.\n\nWe will review 11C-Methionine PET data acquired within 30 days prior to surgery and analyze its principal imaging characteristics with respect to IDH1 mutation status, MGMT promoter methylation and 1p/19q co-deletion. These markers will be studied on tumor tissue obtained at surgery, used for diagnostic purposes and stored in paraffin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will recruit a maximum number of 145 patients with glioma operated in our institution during 2011-2015, of which are available clinical and instrumental data and surgical tumor specimen.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of glioma\n* 11C-Methionine within 30 days before surgery\n\nExclusion Criteria:\n\n* Absence of tumor specimen\n* No clinical data\n* 11C-Methionine can not be evaluated'}, 'identificationModule': {'nctId': 'NCT02518061', 'briefTitle': '11C-Methionine PET as Prognostic Marker of Gliomas', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Role of 11C-Methionine PET for the Prognostic and Molecular Characterization of Gliomas Candidate to Surgery.', 'orgStudyIdInfo': {'id': '1418'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This is a retrospective study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'overallOfficials': [{'name': 'Egesta Lopci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanitas Clinical and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}