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Ultrasound and Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Contrast-enhanced Ultrasound
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Contrast-enhanced Ultrasound, Ultrasound Contrast agents, microbubbles, breast cancer, chemotherapy, vascularization

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Neoadjuvant chemotherapy is programmed when an epithelial carcinoma is diagnosed by histology. Performance status = 0, 1 or 2 No previous surgery or local radiotherapy Exclusion Criteria: Psychiatric disorders Vital threat due to other disease Vital prognosis < 3 months Biopsy of the lesion performed within 1 month before the ultrasonography Patient known to have a coronary syndrome Unstable angina and myocardial infarction Acute cardiac failure, Class III/IV cardiac failure Several arrhythmias Acute endocarditis Prosthetic valves

Sites / Locations

  • University Hospital of Tours

Outcomes

Primary Outcome Measures

From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves

Secondary Outcome Measures

Full Information

First Posted
October 26, 2005
Last Updated
February 19, 2007
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT00245869
Brief Title
Ultrasound and Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
Official Title
Contrast-Enhanced Ultrasound and Neoadjuvant Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Tours

4. Oversight

5. Study Description

Brief Summary
This study intends to assess the ability of contrast-enhanced ultrasound to make the efficacy of chemotherapy in breast cancer precise. This 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. An ultrasound will be performed before the initiation, and after the second and the last dose of chemotherapy. To investigate the changes occurring in the vascularization of tumors, we will use an intravascular ultrasound contrast agent SonoVue (sulphur hexafluoride microbubbles). This 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Contrast-enhanced Ultrasound, Ultrasound Contrast agents, microbubbles, breast cancer, chemotherapy, vascularization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Contrast-enhanced Ultrasound
Primary Outcome Measure Information:
Title
From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Neoadjuvant chemotherapy is programmed when an epithelial carcinoma is diagnosed by histology. Performance status = 0, 1 or 2 No previous surgery or local radiotherapy Exclusion Criteria: Psychiatric disorders Vital threat due to other disease Vital prognosis < 3 months Biopsy of the lesion performed within 1 month before the ultrasonography Patient known to have a coronary syndrome Unstable angina and myocardial infarction Acute cardiac failure, Class III/IV cardiac failure Several arrhythmias Acute endocarditis Prosthetic valves
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Tranquart, PR
Organizational Affiliation
Centre d'Innovation Technologique - CHRU Tours
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Catherine LABBE, MD
Organizational Affiliation
CRLCC René Gauducheau 44805 ST HERBLAIN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15657523
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.
Results Reference
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PubMed Identifier
15010893
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.
Results Reference
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PubMed Identifier
7584949
Citation
Folkman J. Angiogenesis in cancer, vascular, rheumatoid and other disease. Nat Med. 1995 Jan;1(1):27-31. doi: 10.1038/nm0195-27.
Results Reference
background
PubMed Identifier
9881956
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.
Results Reference
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PubMed Identifier
10656442
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.
Results Reference
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PubMed Identifier
10764428
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.
Results Reference
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PubMed Identifier
10764429
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.
Results Reference
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PubMed Identifier
14510263
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.
Results Reference
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PubMed Identifier
14555529
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.
Results Reference
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PubMed Identifier
12767017
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.
Results Reference
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PubMed Identifier
6718687
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.
Results Reference
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Ultrasound and Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response

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