Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT01432002
Status:
UNKNOWN
Last Update Posted:
2022-12-21
First Post:
2011-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FDG-PET/CT for Simulation and Radiation Treatment Planning of Early 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-18', 'studyFirstSubmitDate': '2011-09-02', 'studyFirstSubmitQcDate': '2011-09-08', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drawing of target volumes', 'timeFrame': 'Up to 12 weeks after surgery', 'description': 'Compare the drawing of target volumes using the PET/CT, PET/IRM information, or without these imaging informations.'}], 'secondaryOutcomes': [{'measure': 'Correlate the FDG PET/CT PET/IRM with surgical pathology findings', 'timeFrame': 'Up to 12 weeks after surgery', 'description': 'Compare the pre-operative imaging information with histopathological description of the resected primary tumor, and with the extent of lymph node involvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast carcinoma', 'FDG', 'PET/CT', 'PET/IRM'], 'conditions': ['Breast Neoplasm']}, 'referencesModule': {'references': [{'pmid': '18259702', 'type': 'BACKGROUND', 'citation': 'Bral S, Vinh-Hung V, Everaert H, De Coninck P, Storme G. The use of molecular imaging to evaluate radiation fields in the adjuvant setting of breast cancer: a feasibility study. Strahlenther Onkol. 2008 Feb;184(2):100-4. doi: 10.1007/s00066-008-1769-7.'}, {'pmid': '22777335', 'type': 'BACKGROUND', 'citation': 'Vinh-Hung V, Everaert H, Lamote J, Voordeckers M, van Parijs H, Vanhoeij M, Verfaillie G, Fontaine C, Vees H, Ratib O, Vlastos G, De Ridder M. Diagnostic and prognostic correlates of preoperative FDG PET for breast cancer. Eur J Nucl Med Mol Imaging. 2012 Oct;39(10):1618-27. doi: 10.1007/s00259-012-2181-1. Epub 2012 Jul 10.'}, {'pmid': '26050658', 'type': 'BACKGROUND', 'citation': 'Tabouret-Viaud C, Botsikas D, Delattre BM, Mainta I, Amzalag G, Rager O, Vinh-Hung V, Miralbell R, Ratib O. PET/MR in Breast Cancer. Semin Nucl Med. 2015 Jul;45(4):304-21. doi: 10.1053/j.semnuclmed.2015.03.003.'}, {'pmid': '33689151', 'type': 'BACKGROUND', 'citation': 'Vinh-Hung V, Everaert H, Gorobets O, Van Parijs H, Verfaillie G, Vanhoeij M, Storme G, Fontaine C, Lamote J, Perrin J, Farid K, Nguyen NP, Verschraegen C, De Ridder M. Breast cancer preoperative 18FDG-PET, overall survival prognostic separation compared with the lymph node ratio. Breast Cancer. 2021 Jul;28(4):956-968. doi: 10.1007/s12282-021-01234-z. Epub 2021 Mar 10.'}, {'pmid': '35582655', 'type': 'BACKGROUND', 'citation': 'Perrin J, Farid K, Van Parijs H, Gorobets O, Vinh-Hung V, Nguyen NP, Djassemi N, De Ridder M, Everaert H. Is there utility for fluorine-18-fluorodeoxyglucose positron-emission tomography scan before surgery in breast cancer? A 15-year overall survival analysis. World J Clin Oncol. 2022 Apr 24;13(4):287-302. doi: 10.5306/wjco.v13.i4.287.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is:\n\n* to assess the potential benefits of 18F-\\[FDG\\] PET/CT and PET/MRI for operable breast cancer in order to define the size and location of the primary tumor, as well as axillary, supraclavicular and internal mammary lymph nodes.\n* to apply the imaging results to the simulation and the radiation treatment planning and partial breast for 3-D radiation treatment and partial breast irradiation with intensity modulated radiation treatment (IMRT).', 'detailedDescription': 'Pre-operative FDG PET/CT, and in option PET/IRM, are intended for women with histologically confirmed operable clinically node-negative breast cancer, in whom breast conserving and post-operative radiotherapy are planned.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with operable clinically node-negative breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed breast carcinoma\n* Clinical stage T1-2 N0 M0\n* Age \\> 18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* WHO performance index 3\n* Premenopausal women without contraception\n* Gestation\n* Lactating\n* Prior surgery or radiotherapy on the same breast\n* Unable to understand study participation\n* Bilateral breast cancer\n* Prior CT thorax-abdomen and breast MRI within 4 months of interview\n* Presence of electromechanical implant and/or body ferromagnetic material\n* Previous history of renal insufficiency requiring dialysis and/or hospitalisation\n* Ureum and/or creatinine within 2 weeks of interview above lab's reference limits\n* History of contrast allergy\n* Hyperthyroidy\n* Claustrophobia."}, 'identificationModule': {'nctId': 'NCT01432002', 'briefTitle': 'FDG-PET/CT for Simulation and Radiation Treatment Planning of Early Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Application of 18F-[FDG] PET/CT to Simulation and Planning of Radiotherapy (RT) for Breast Cancer. Definition of Target Volume for 3-D RT and for Partial Breast Irradiation (PBI) by IMRT Technique', 'orgStudyIdInfo': {'id': 'HUG 07-153'}}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Radiation oncology, Geneva University Hospitals', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Vincent Vinh-Hung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiation Oncology, Geneva University Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Privat Docent', 'investigatorFullName': 'Vincent Vinh-Hung', 'investigatorAffiliation': 'University of Geneva, Switzerland'}}}}