Breast CancerNCT00245869
Ultrasound and Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
A study testing Contrast-enhanced Ultrasound in people with Breast Cancer, run by University Hospital, Tours at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Contrast-enhanced Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2004to Feb 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Acute cardiac failure, Class III/IV cardiac failure
- Several arrhythmias
- Acute endocarditis
- Prosthetic valves
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast-Enhanced Ultrasound and Neoadjuvant Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Contrast-enhanced Ultrasound
- Keywords
- Contrast-enhanced Ultrasound, Ultrasound Contrast agents, microbubbles, breast cancer, chemotherapy, vascularization
- Medical subject headings
- Breast Neoplasms, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced UltrasoundProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startMar 2004
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Investigators
- François Tranquart, PR, Study director, Centre d'Innovation Technologique - CHRU ToursCatherine LABBE, MD, Principal investigator, CRLCC René Gauducheau 44805 ST HERBLAIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245869
- Sponsor's protocol ID
- CT03-FD/COR
- Status last verified
- Jul 2006
- First submitted
- 26 Oct 2005
- Last updated
- 21 Feb 2007
- Results posted
- No
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. doi: 10.2325/jbcs.12.45.
PubMed 15657523Watermann 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.
PubMed 15010893Folkman J. Angiogenesis in cancer, vascular, rheumatoid and other disease. Nat Med. 1995 Jan;1(1):27-31. doi: 10.1038/nm0195-27.
PubMed 7584949Hansen 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.
PubMed 9881956Hansen 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.
PubMed 10656442Smith 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.
PubMed 10764428Schelling 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.
PubMed 10764429Denis 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.
PubMed 14510263Denis 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.
PubMed 14555529Kook 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.
PubMed 12767017Solesvik 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.
PubMed 6718687
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Enhanced Ultrasound and Neoadjuvant Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response
- ClinicalTrials.gov ID
- NCT00245869
- Acronym / sponsor ID
- CT03-FD/COR
- Conditions
- Breast Cancer
- Keywords
- Contrast-enhanced Ultrasound, Ultrasound Contrast agents, microbubbles, breast cancer, chemotherapy, vascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Feb 2007
- First posted
- 28 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced Ultrasound | Procedure or surgery | – |
Primary outcome
From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2007.
- Background: PubMed 15657523Singh 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.
- Background: PubMed 15010893Watermann 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.
- Background: PubMed 7584949Folkman J. Angiogenesis in cancer, vascular, rheumatoid and other disease. Nat Med. 1995 Jan;1(1):27-31. doi: 10.1038/nm0195-27.
- Background: PubMed 9881956Hansen 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.
- Background: PubMed 10656442Hansen 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.
- Background: PubMed 10764428Smith 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.
- Background: PubMed 10764429Schelling 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.
- Background: PubMed 14510263Denis 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.
- Background: PubMed 14555529Denis 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.
- Background: PubMed 12767017Kook 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.
- Background: PubMed 6718687Solesvik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Tranquart, PR study director
Centre d'Innovation Technologique - CHRU Tours
Catherine LABBE, MD principal investigator
CRLCC René Gauducheau 44805 ST HERBLAIN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced Ultrasound in people with Breast Cancer, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00245869, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2007.