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

Purpose

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.

Condition	Intervention
Breast Cancer	Procedure: Contrast-enhanced Ultrasound

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Contrast-Enhanced Ultrasound and Neoadjuvant Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	March 2004
Estimated Study Completion Date:	February 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245869

Locations

France
University Hospital of Tours
Tours, France, 37044

Sponsors and Collaborators

University Hospital, Tours

Investigators

Study Director:	François Tranquart, PR	Centre d'Innovation Technologique - CHRU Tours
Principal Investigator:	Catherine LABBE, MD	CRLCC René Gauducheau 44805 ST HERBLAIN

More Information

Publications:

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.

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.

Folkman J. Angiogenesis in cancer, vascular, rheumatoid and other disease. Nat Med. 1995 Jan;1(1):27-31. Review.

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.

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.

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.

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.

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.

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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00245869 History of Changes
Other Study ID Numbers:	CT03-FD/COR
Study First Received:	October 26, 2005
Last Updated:	February 19, 2007
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:

Contrast-enhanced Ultrasound
Ultrasound Contrast agents, microbubbles
breast cancer
chemotherapy
vascularization

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013