Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-29 @ 1:37 AM
Study NCT ID:
NCT03429868
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2018-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET and MRI in Prognosis Prediction of NPC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2018-02-06', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'Being calculated from the date of diagnosis to the date of death or censor at the date of the last follow- up for surviving patients.'}], 'secondaryOutcomes': [{'measure': 'Recurrence-free survival', 'timeFrame': '3 years', 'description': 'The time between the end of treatment and the date of recurrence (tumor relapse or death) or censor at the date of the last follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal carcinoma', 'Nead neck cancer', 'Prognosis', 'PET', 'MRI'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '40601020', 'type': 'DERIVED', 'citation': 'Chan SC, Ng SH, Yeh CH, Lin YC, Lin CY, Wang JH, Cheng NM, Chen SH, Chang KP, Hsieh JC. Prognostic utility of 18F-FDG PET/MRI with intravoxel incoherent motion imaging in nasopharyngeal carcinoma. Eur J Nucl Med Mol Imaging. 2025 Dec;53(1):338-349. doi: 10.1007/s00259-025-07425-6. Epub 2025 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'Nasopharyngeal carcinoma (NPC) differs from other head and neck malignancies terms of its epidemiology, pathology, and treatment outcome. Integrated PET/MRI is a new imaging modality, which can simultaneously acquire PET and MRI images. Considering the lack of reports on the use of hybrid PET/MRI systems in prognosis prediction in NPC, the investigators conduct this prospective study to investigate the roles of integrated PET/MRI parameters for predicting treatment outcome and prognosis in patients with NPC.', 'detailedDescription': "1. Background:\n\n Nasopharyngeal carcinoma (NPC) has a higher local tumor control rate but a higher incidence of distant metastasis compared with squamous cell carcinomas of other regions of the head and neck. Thus, it's usually considered a distinct study group. A reliable clinical prognostic factor for NPC patients is still lacking. Positron emission tomography (PET) with 2- \\[fluorine- 18\\]fluoro-2-deoxy-D-glucose (18F-FDG)/computed tomography (CT) has been used extensively for diagnosis and assessment of prognosis in NPC in recent years. Several PET-derived imaging parameters such as standardized uptake value (SUV), metabolic tumor volume (MTV), or total lesion glycolysis (TLG) have been proposed as potential prognosticators in NPC. MRI functional parameters also play a role to assess the cellular or molecular change of head and neck cancer. Diffusion-weighted MR imaging (DWI) is a technique, which can quantify the diffusion of water molecules in tissues using apparent diffusion coefficient (ADC). ADC is inversely correlated with cellular density. Dynamic contrast-enhanced perfusion MR imaging (DCE-MRI) is another MRI technique based on sequential imaging obtained during the passage of a contrast of agent through the tissue. It enables probing the microvascular environment in the tumor tissue.\n\n Integrated PET/MRI is a new imaging modality, which can simultaneously acquire PET and MRI images. Traditionally, PET and MRI images were acquired on different dates and were fused by commercial software. Problems caused by a separate system include SUV or MRI parameters were reported to be different if the scans were acquired on different days. Simultaneous acquisition of PET and MRI images would solve these problems.\n2. Aim: The investigators conduct this prospective study to investigate the roles of integrated PET/MRI imaging parameters for predicting treatment outcomes and prognosis in patients with NPC.\n3. Study design:\n\nPatients: All patients receive whole-body 18F-FDG PET/MRI following 18F-FDG-PET/CT on the same day. For tumor staging, the 7th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) cancer staging system is used. The patients with stage I disease are treated with definitive radiation therapy alone, while patients with stage II-IVB are treated with concurrent chemoradiotherapy. Patients with metastatic disease (stage IVC) are treated with standard platinum-based chemotherapy.\n\n18F-FDG PET/CT: All study patients fast for at least 6 h before 18F-FDG PET/CT imaging. Scans are performed using a Biograph mCT scanner (Siemens Medical Solutions, Malvern, PA, USA) consisting of a four-ring PET scanner (axial field-of-view \\[FOV\\] = 22.1 cm, transaxial FOV = 70 cm) and a 40-section CT scanner.\n\nWhole-body 18F-FDG PET/MRI: PET/MRI is performed on a Biograph mMR (Siemens Healthcare, Erlangen, Germany) following the PET/CT scan on the same day. The PET/MRI system is equipped with 3-T magnetic field strength, total imaging matrix coil technology covering the entire body with multiple integrated radiofrequency surface coils, and a fully functional PET system with avalanche photodiode technology embedded in the magnetic resonance gantry.\n\nImage interpretation: The PET/CT and PET/MRI data sets are evaluated on dedicated workstations (Syngo.via, Siemens Healthcare, Erlangen, Germany). The readers interpret the (1) MR images from PET/MRI, (2) 18F-FDG PET/MRI images, and (3) 18F-FDG PET/CT images independently. They are aware of the study protocol but are blinded to the results from the other imaging modalities. Imaging parameters including SUV, MTV, TLG, ADC, Ktrans, Ve, and Vp are calculated.\n\nStatistical analysis: Overall survival (OS) and recurrence-free survival (RFS) serves as the main outcome measures. OS is calculated from the date of diagnosis to the date of death or censored at the date of the last follow-up for surviving patients. RFS is defined as the time between the end of treatment and the date of recurrence (tumor relapse or death) or censored at the date of the last follow-up. The cutoff values for the clinical variables and imaging parameters in survival analysis are determined using the log-rank test based on the RFS and OS rates observed in the entire study cohort. Survival curves are plotted using the Kaplan-Meier method. The effect of each individual variable is initially evaluated using univariate analysis. Cox regression models are used to identify the predictors of survival. Two-tailed P values \\< 0.05 are considered statistically significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Biopsy proven primary nasopharyngeal carcinoma\n2. Age \\> or = 20\n3. Willing to receive therapy\n4. The ability to provide written informed consent and receive the scheduled scans\n\nExclusion Criteria:\n\n1. Woman with pregnancy or during lactation\n2. A history of other malignancies or concomitant cancers in different anatomical locations\n3. Not suitable to receive the PET scan such as serum glucose levels of \\> 200 mg/dL or space phobia'}, 'identificationModule': {'nctId': 'NCT03429868', 'briefTitle': 'PET and MRI in Prognosis Prediction of NPC', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Prognostic Value of the Integrated PET/MRI in Patients With Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'NSC 104-2314-B-182A-084-MY3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'integrated PET/MRI', 'description': 'The participants receive an integrated 18F-FDG PET/MRI during tumor staging.', 'interventionNames': ['Device: integrated PET/MRI']}], 'interventions': [{'name': 'integrated PET/MRI', 'type': 'DEVICE', 'description': 'The participants receive an integrated 18F-FDG PET/MRI scan in addition to the conventional 18F-FDG PET/CT on the same day during tumor staging.\n\nWhole body 18F-FDG PET/CT is performed one hour after injection of 10mCi of 18F-FDG. 18F-FDG PET/MRI is done after the PET/CT scan. And no additional 18F-FDG is given to the patients in the PET/MRI scan.', 'armGroupLabels': ['integrated PET/MRI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Linkou Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Sheng-Chieh Chan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}