Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
Study NCT ID:
NCT04359732
Status:
RECRUITING
Last Update Posted:
2025-02-25
First Post:
2020-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Response to nCRT for GEJ Cancer Using a Fully Integrated PET/MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 155}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2020-04-20', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to neoadjuvant treatment -MRI', 'timeFrame': '0-36 months', 'description': 'MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints'}, {'measure': 'Response to neoadjuvant treatment -PET', 'timeFrame': '0-36 months', 'description': 'PET component -quantitative evaluation and delta between timepoints'}, {'measure': 'Response to neoadjuvant treatment - Histology', 'timeFrame': '0-36 months', 'description': 'Evaluate degree of tumor regression after neoadjuvant therapy according to the Mandard Tumour regression grade ; integrated Immunohistochemistry'}, {'measure': 'Response to neoadjuvant treatment -Radiomics', 'timeFrame': '0-36 months', 'description': 'Radiomic features extracted from hybrid imaging'}, {'measure': 'Imaging parameters as potential predictors of tumor response', 'timeFrame': '0- 48 months', 'description': 'Select imaging parameters that can be considered potential predictors of the responder/non-responder status assessment'}], 'secondaryOutcomes': [{'measure': 'Early regression model (ERI)', 'timeFrame': '0- 60 months', 'description': 'Evaluate the ERI model as a predictor of histological response (TRG grade) based on MRI tumor volume assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['response', 'neoadjuvant', 'PET/MRI', 'radiomics', 'GEJ cancer'], 'conditions': ['Esophageal Cancer', 'Esophageal Neoplasms']}, 'descriptionModule': {'briefSummary': 'Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).', 'detailedDescription': "This is a prospective, observational single center study which plans to enroll patients with biopsy proven potentially resectable esophageal or junctional cancer scheduled to receive nCRT (CROSS regimen) prior to surgery.\n\nThe study aims to evaluate Routine pre-treatment work-up includes PET to stage the tumour extension.\n\n* PET/MRI (Magnetic resonance imaging) will replace the PET component of CT(computed tomography)\n* An additional intermediate 18-FDG (Fluorodeoxyglucose) PET/MRI will be performed during nCRT\n* Post nCRT imaging, as required prior to surgery, will be PET/MRI six weeks after treatment completion.\n* 8-12 weeks post nCRT completion surgery will be performed, based on each patient's performance status and response to nCRT\n* Histopathological samples of the excised tumor and lymph nodes will be used for diagnosis, staging and description of qualitative and quantitative parameters Routine clinical and radiological follow-up for 24 months (for the scope of this study) will follow the standard clinical workflow assigned to this group of patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* biopsy-proven esophageal or junctional carcinomas (either adenocarcinoma (AC) or squamous cell carcinoma (SCC) for which an Ivor-Lewis transthoracic esophagectomy with supramesocolic and mediastinal lymphadenectomy is indicated;\n* visible tumor on pre-treatment imaging;\n* ≥ 18 years of age;\n* signed informed consent.\n\nExclusion Criteria:\n\n* \\- incomplete preoperative imaging assessment;\n* contraindications to neoadjuvant treatment;\n* contraindications to preoperative imaging (such as pacemaker, allergy to contrast agents);\n* inability to complete imaging examinations (i.e. severe claustrophobia);\n* contraindication to surgery (comorbidities, distant metastatic disease (imaging confirmed));\n* pregnant or lactating women\n* severe hypersensitivity to gadobutrol or fludeoxyglucose F18.'}, 'identificationModule': {'nctId': 'NCT04359732', 'acronym': 'Escape', 'briefTitle': 'Assessment of Response to nCRT for GEJ Cancer Using a Fully Integrated PET/MRI', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Prediction of Assessment of Response to Neoadjuvant Chemo-Radio-Therapy (nCRT) for Esophageal and Gastroesophageal Junction Cancer (GEJ) Using a Fully Integrated PET/MRI', 'orgStudyIdInfo': {'id': 'Escape'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hybrid PET/MRI', 'description': 'For the purposes of the study, in addition to standard imaging (EUS and CT scan), a fully integrated hybrid PET/MRI (PET/MRI) study with FDG will replace the Standard PET (pre-surgical evaluation) used for evaluating distant metastases and will be considered as the add-on procedure at three time points. The additional evaluation for patients is that during nCRT treatment.', 'interventionNames': ['Other: hybrid PET/MRI']}], 'interventions': [{'name': 'hybrid PET/MRI', 'type': 'OTHER', 'description': 'An additional intermediate 18-FDG PET/MRI will be performed during neoadjuvant chemo-radiation therapy. Routine pre-treatment work-up PET/MRI will replace PET alone.', 'armGroupLabels': ['Hybrid PET/MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stephanie Steidler, PhD', 'role': 'CONTACT', 'email': 'steidler.stephanie@hsr.it', 'phone': '+390226436111'}, {'name': 'Francesco De Cobelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Riccardo Rosati, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Deaprtment of Radiology, IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Francesco De Cobelli, MD', 'role': 'CONTACT', 'email': 'decobelli.francesco@hsr.it', 'phone': '+3926432529'}, {'name': 'Stephanie Steidler', 'role': 'CONTACT', 'email': 'steidler.stephanie@hsr.it', 'phone': '+3926436111'}], 'overallOfficials': [{'name': 'Francesco De Cobelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Ospedale San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'Associazione Italiana per la Ricerca sul Cancro', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Chair Radiology Department', 'investigatorFullName': 'Francesco De Cobelli', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}