Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-28 @ 11:44 AM
Study NCT ID:
NCT05464992
Status:
RECRUITING
Last Update Posted:
2023-01-05
First Post:
2022-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], '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'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2036-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2022-07-12', 'studyFirstSubmitQcDate': '2022-07-15', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2036-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obtention, from a set of brain PET-MRI images, of an intratissular pH mapping in patients with glioma or brain metastases', 'timeFrame': 'through study completion, up to 14 years', 'description': 'Evaluation at the cerebral level on the acquisition images of residual volume in MRI'}, {'measure': 'Obtention, from a set of brain PET-MRI images, of an intratissular pH mapping in patients with glioma or brain metastases', 'timeFrame': 'through study completion, up to 14 years', 'description': 'Evaluation at the cerebral level on the acquisition images of tumoral metabolic activity in PET'}], 'secondaryOutcomes': [{'measure': 'Correlate intratissular pH mapping and location of recurrence', 'timeFrame': 'through study follow-up, up to 10 years'}, {'measure': 'Correlate average pH of the tumor and histopathology', 'timeFrame': 'through study follow-up, up to 10 years'}, {'measure': 'Correlate average pH of the tumor and Disease-Free Survival (DFS)', 'timeFrame': 'through study follow-up, up to 10 years'}, {'measure': 'Correlate average pH of the tumor and Overall survival (OS)', 'timeFrame': 'through study follow-up, up to 10 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma', 'Brain Metastases']}, 'descriptionModule': {'briefSummary': 'Standard Magnetic Resonance Imaging (MRI) is based on the excitation of hydrogen nuclei that are presents in water molecules, which abundance in human body allows for obtention of superior contrast. However, assessing the presence of other molecules than water in tissues is also of great clinical interest to probe metabolites related to physiological body function and pathological conditions.\n\nChemical exchange saturation transfer (CEST) allow to overcome some limitations of proton magnetic resonance spectroscopy (1H-MRS) by exploiting chemical properties of the targeted molecule through a continuous process of re-saturation and exchange, and thus detecting it with increased sensitivity, from two orders of magnitude. Moreover, CEST technique is based on imaging sequences and can therefore benefit from well-known fast acquisition strategies, as well as improved spatial resolution.', 'detailedDescription': 'For this study the investigators propose to include an additional CEST sequence in standard PET/MRI exam in order to obtain a cartography with biochemical informations from tissues in patients with glioma or brain metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients admitted to the Nuclear Medicine and Molecular Imaging department of ICANS (Institut de cancérologie strasbourg Europe) for a PET/MRI exam dedicated to:\n\n* Preoperative evaluation of a cerebral expansion lesion\n* Evaluation of glioma recurrences\n* Evaluation of brain metastases\n* Evaluation of recurrence of metastases\n\nExclusion Criteria:\n\n* Contraindication to the realization of an MRI\n* Minor or patients placed under guardianship or supervision\n* Patients deprived of liberty\n* Patients placed under judicial protection\n* Patients that are not able to express their consent\n* Pregnant and breastfeeding women'}, 'identificationModule': {'nctId': 'NCT05464992', 'acronym': 'GlioCEST', 'briefTitle': 'Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI', 'organization': {'class': 'OTHER', 'fullName': 'Institut de cancérologie Strasbourg Europe'}, 'officialTitle': 'Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI', 'orgStudyIdInfo': {'id': '2022-005'}, 'secondaryIdInfos': [{'id': '2022-A00910-43', 'type': 'OTHER', 'domain': 'ID-RCB Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with glioma or brain metastases', 'interventionNames': ['Other: Additional CEST sequences during PET/MRI exam']}], 'interventions': [{'name': 'Additional CEST sequences during PET/MRI exam', 'type': 'OTHER', 'description': 'CE-Marked Advanced Technology Software Modules (ATSM) for Magnetic Resonance Imaging from General Electric Healthcare', 'armGroupLabels': ['Patients with glioma or brain metastases']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Manon VOEGELIN', 'role': 'CONTACT', 'email': 'promotion-rc@icans.eu'}, {'name': 'Izzie-Jacques NAMER, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Caroline BUND, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'France Institut de cancérologie Strasbourg Europe', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Manon VOEGELIN', 'role': 'CONTACT', 'email': 'promotion-rc@icans.eu', 'phone': '(0)368339523', 'phoneExt': '33'}, {'name': 'Claire VIT', 'role': 'CONTACT', 'email': 'promotion-rc@icans.eu', 'phone': '(0)368339523', 'phoneExt': '33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de cancérologie Strasbourg Europe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}