Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-20 @ 5:32 PM
Study NCT ID:
NCT01942759
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2013-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prognostic Value of FDG PET/CT and Diffusion-weighed Imaging on Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-08', 'studyFirstSubmitDate': '2013-09-02', 'studyFirstSubmitQcDate': '2013-09-11', 'lastUpdatePostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the relationships between both SUVmax and ADC and clinicopathological prognostic factors', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast Neoplasms', 'Positron-Emission Tomography', 'Diffusion Magnetic Resonance Imaging'], 'conditions': ['Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine findings of positron emission tomography and diffusion weighted magnetic resonance in primary lesion and axillary metastasis of breast cancer and compare of two imaging modality in these patients.', 'detailedDescription': 'We aimed that to correlate both primary lesion 18F-fluorodeoxyglucose (FDG) maximum standardized uptake value (SUVmax) and diffusion-weighted imaging (DWI) apparent diffusion coefficient (ADC) with clinicopathological prognostic factors and compare the prognostic value of these indexes in breast cancer in this study. The evaluated and compared parameters are SUVmax and ADC according to age, tumour size, lymph node metastasis, receptor status, histologic grade, modified Nottingham prognostic index.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients with breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosis of breast cancer for which surgical intervention is planned\n\nExclusion Criteria:\n\n* patients received neoadjuvant chemotherapy\n* before breast surgery'}, 'identificationModule': {'nctId': 'NCT01942759', 'briefTitle': 'The Prognostic Value of FDG PET/CT and Diffusion-weighed Imaging on Breast Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bagcilar Training and Research Hospital'}, 'officialTitle': 'The Prognostic Value of FDG PET/CT and Diffusion-weighed Imaging on Detection of Primary Tumor and Axillary Metastasis for Breast Cancer: SUVMax Against to ADC', 'orgStudyIdInfo': {'id': 'BC-PET-MR-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Histologic grade', 'description': 'According to the modified criteria of Bloom and Richardson grading system: grade 1, 2 and 3'}, {'label': 'Axillary metastasis', 'description': 'Group A: axillary lymph node metastasis Group B: no axillary lymphatic metastasis'}, {'label': 'Modified Nottingham prognostic index', 'description': 'NPI = pathological tumour size (cm) × 0.2 + lymph node stage (1, 2 or 3) + histological grade (1, 2 or 3)\n\nThe cut-off points of the index were 3.4 and 5.4 to divide patients into the good (≤3.4), moderate (3.41-5.4) and poor (\\>5.4) prognostic groups'}, {'label': 'Oestrogen receptor status', 'description': 'Negative Positive'}, {'label': 'Progesterone receptor status', 'description': 'Negative Positive'}, {'label': 'HER-2 neu status', 'description': 'Negative Positive'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bagcilar Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'AYNUR OZEN, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bagcilar Training & Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bagcilar Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Aynur Ozen', 'investigatorFullName': 'Aynur Ozen', 'investigatorAffiliation': 'Bagcilar Training and Research Hospital'}}}}