Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT00245869
Status:
COMPLETED
Last Update Posted:
2007-02-21
First Post:
2005-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound and Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}], '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'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2007-02'}, 'lastUpdateSubmitDate': '2007-02-19', 'studyFirstSubmitDate': '2005-10-26', 'studyFirstSubmitQcDate': '2005-10-26', 'lastUpdatePostDateStruct': {'date': '2007-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves'}]}, 'conditionsModule': {'keywords': ['Contrast-enhanced Ultrasound', 'Ultrasound Contrast agents, microbubbles', 'breast cancer', 'chemotherapy', 'vascularization'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '15657523', 'type': 'BACKGROUND', 'citation': 'Singh S, Pradhan S, Shukla RC, Ansari MA, Kumar A. Color Doppler ultrasound as an objective assessment tool for chemotherapeutic response in advanced breast cancer. Breast Cancer. 2005;12(1):45-51. doi: 10.2325/jbcs.12.45.'}, {'pmid': '15010893', 'type': 'BACKGROUND', 'citation': 'Watermann D, Madjar H, Sauerbrei W, Hirt V, Prompeler H, Stickeler E. Assessment of breast cancer vascularisation by Doppler ultrasound as a prognostic factor of survival. Oncol Rep. 2004 Apr;11(4):905-10.'}, {'pmid': '7584949', 'type': 'BACKGROUND', 'citation': 'Folkman J. Angiogenesis in cancer, vascular, rheumatoid and other disease. Nat Med. 1995 Jan;1(1):27-31. doi: 10.1038/nm0195-27.'}, {'pmid': '9881956', 'type': 'BACKGROUND', 'citation': 'Hansen S, Grabau DA, Rose C, Bak M, Sorensen FB. Angiogenesis in breast cancer: a comparative study of the observer variability of methods for determining microvessel density. Lab Invest. 1998 Dec;78(12):1563-73.'}, {'pmid': '10656442', 'type': 'BACKGROUND', 'citation': 'Hansen S, Grabau DA, Sorensen FB, Bak M, Vach W, Rose C. The prognostic value of angiogenesis by Chalkley counting in a confirmatory study design on 836 breast cancer patients. Clin Cancer Res. 2000 Jan;6(1):139-46.'}, {'pmid': '10764428', 'type': 'BACKGROUND', 'citation': 'Smith IC, Welch AE, Hutcheon AW, Miller ID, Payne S, Chilcott F, Waikar S, Whitaker T, Ah-See AK, Eremin O, Heys SD, Gilbert FJ, Sharp PF. Positron emission tomography using [(18)F]-fluorodeoxy-D-glucose to predict the pathologic response of breast cancer to primary chemotherapy. J Clin Oncol. 2000 Apr;18(8):1676-88. doi: 10.1200/JCO.2000.18.8.1676.'}, {'pmid': '10764429', 'type': 'BACKGROUND', 'citation': 'Schelling M, Avril N, Nahrig J, Kuhn W, Romer W, Sattler D, Werner M, Dose J, Janicke F, Graeff H, Schwaiger M. Positron emission tomography using [(18)F]Fluorodeoxyglucose for monitoring primary chemotherapy in breast cancer. J Clin Oncol. 2000 Apr;18(8):1689-95. doi: 10.1200/JCO.2000.18.8.1689.'}, {'pmid': '14510263', 'type': 'BACKGROUND', 'citation': 'Denis F, Bougnoux P, Paon L, le Floch O, Tranquart F. Radiosensitivity of rat mammary tumors correlates with early vessel changes assessed by power Doppler sonography. J Ultrasound Med. 2003 Sep;22(9):921-9. doi: 10.7863/jum.2003.22.9.921.'}, {'pmid': '14555529', 'type': 'BACKGROUND', 'citation': 'Denis F, Colas S, Chami L, Louisot P, Le Floch O, Tranquart F, Bougnoux P. Changes in tumor vascularization after irradiation, anthracyclin, or antiangiogenic treatment in nitrosomethyl ureas-induced rat mammary tumors. Clin Cancer Res. 2003 Oct 1;9(12):4546-52.'}, {'pmid': '12767017', 'type': 'BACKGROUND', 'citation': 'Kook SH, Kwag HJ. Value of contrast-enhanced power Doppler sonography using a microbubble echo-enhancing agent in evaluation of small breast lesions. J Clin Ultrasound. 2003 Jun;31(5):227-38. doi: 10.1002/jcu.10172.'}, {'pmid': '6718687', 'type': 'BACKGROUND', 'citation': 'Solesvik OV, Rofstad EK, Brustad T. Vascular changes in a human malignant melanoma xenograft following single-dose irradiation. Radiat Res. 1984 Apr;98(1):115-28.'}]}, 'descriptionModule': {'briefSummary': 'This study intends to assess the ability of contrast-enhanced ultrasound to make the efficacy of chemotherapy in breast cancer precise.\n\nThis real-time noninvasive and feasible imaging technique allows us, the investigators at University Hospital Tours, to evaluate early vascular changes of breast tumors during treatment. These vascular changes may precede long-term tumoral regression. Imaging of primary breast lesions may be of value in the prediction of late treatment response.\n\nAn ultrasound will be performed before the initiation, and after the second and the last dose of chemotherapy.\n\nTo investigate the changes occurring in the vascularization of tumors, we will use an intravascular ultrasound contrast agent SonoVue (sulphur hexafluoride microbubbles).\n\nThis agent is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging of angiogenesis.', 'detailedDescription': 'The main objective of the study is to evaluate the early vascular changes of the tumor during neoadjuvant chemotherapy compared to the clinical or MRI or histological response.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast tumor (size equal to or greater than 3 cm.). Patients with diagnosis of benign breast tumor based on biopsy will be excluded from the study after the first ultrasound examination.\n* Neoadjuvant chemotherapy is programmed when an epithelial carcinoma is diagnosed by histology.\n* Performance status = 0, 1 or 2\n* No previous surgery or local radiotherapy\n\nExclusion Criteria:\n\n* Psychiatric disorders\n* Vital threat due to other disease\n* Vital prognosis \\< 3 months\n* Biopsy of the lesion performed within 1 month before the ultrasonography\n* Patient known to have a coronary syndrome\n* Unstable angina and myocardial infarction\n* Acute cardiac failure, Class III/IV cardiac failure\n* Several arrhythmias\n* Acute endocarditis\n* Prosthetic valves'}, 'identificationModule': {'nctId': 'NCT00245869', 'briefTitle': 'Ultrasound and Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Contrast-Enhanced Ultrasound and Neoadjuvant Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response', 'orgStudyIdInfo': {'id': 'CT03-FD/COR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Contrast-enhanced Ultrasound', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'University Hospital of Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'François Tranquart, PR', 'role': 'STUDY_DIRECTOR', 'affiliation': "Centre d'Innovation Technologique - CHRU Tours"}, {'name': 'Catherine LABBE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CRLCC René Gauducheau 44805 ST HERBLAIN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}}}}