Breast TumorsNCT00243698
A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
A study testing SonoVue (sulphur hexafluoride microbubbles) in people with Breast Tumors, run by University Hospital, Tours at 1 site in France.
Trial summary
Ultrasound is a well-established imaging modality for the evaluation of breast disease. The investigators' objective is to characterise the properties of an intravascular ultrasonographic contrast agent SonoVue (sulphur hexafluoride microbubbles) to improve the diagnostic value of the ultrasound examination in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Tumors
- What is being tested?
- SonoVue (sulphur hexafluoride microbubbles)
- Type of treatment
- Injection or infusion
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- May 2004to May 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Woman presenting with: enlarging fibroadenoma (less than 2 cm in diameter or woman over 40 years old with fibroadenoma less than 2 cm in diameter) or suspect malignant nodule (less than 2 cm in diameter) or a cluster of microcalcification or a malignant nodule (size greater than 3 cm) diagnosed with mammography and/or MRI and/or United States (US) examination performed within 1 month before the study.
- Woman scheduled for biopsy or surgery within 1 month from the examination.
Who cannot join
- Patients who have already performed a biopsy on the lesion during investigation
- Any contraindication to perform a contrast-enhanced MRI examination for the patients presenting with a malignant nodule (size greater than 3 cm)
- Patients previously entered in this study or having received an investigational drug within 30 days prior to admission to this study
- Patients with any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or of achieving the study objectives (drug dependence, psychiatric disorders, dementia or other reasons)
- Pregnant or nursing female
- Patient known to have a coronary syndrome
Show all 11Show fewer
- Unstable angina and myocardial infarction
- Acute cardiac failure, Class III/IV cardiac failure
- Severe rhythm disorders
- Acute endocarditis
- Prosthetic valves
Trial locations and contacts
1 site in 1 country.
About this study
Ultrasound is a well-established imaging modality for the evaluation of breast disease.
The investigators' objective is to characterise the properties of an intravascular ultrasonographic contrast agent SonoVue (sulphur hexafluoride microbubbles) to improve the diagnostic value of the ultrasound examination in patients with different breast lesions.
Read more
The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the differentiation between benign and malignant lesions.
SonoVue® (sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging.
Contrast-enhanced ultrasound could provide a non-invasive technique to evaluate the morphology of breast tumour vascularity.
Read the detailed description
The main objective of the study is to evaluate the efficacy of SonoVue® to detect breast lesions and define specific microcirculation patterns in patients with four different type of breast lesions (enlarging fibroadenoma, suspect malignant nodules, microcalcification and large malignant nodules) in comparison with pathological specimens in terms of histology diagnosis and microvessel density evaluation.
- Conditions
- Breast Tumors
- Being tested
- SonoVue (sulphur hexafluoride microbubbles)
- Keywords
- Contrast-enhanced Ultrasound Sonography, Ultrasound Contrast agents, microbubbles, Breast tumors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoVue (sulphur hexafluoride microbubbles)Drug
One contrast enhanced ultrasonography using sonovue / 4.8 ml per injection (maximum of 3 injections)
What is being measured
The primary outcome is the main question the study is designed to answer.
From contrast-enhanced ultrasound: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements.
Measured: Inclusion period
Secondary outcomes (2)
Histology assessments: Microvessel density assessments to evaluate the total amount of microcirculation and the neoangiogenesis microcirculation present in the samples
Measured: inclusion period
Off-line time-intensity curves from contrast-enhanced magnetic resonance imaging (MRI) images (malignant nodule greater than 3 cm in diameter only)
Measured: inclusion period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study startMay 2004
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast TumorsStudies 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
- 59 participants (actual)
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
- NCT00243698
- Sponsor's protocol ID
- CT03-FT/SEN
- Status last verified
- Nov 2007
- First submitted
- 21 Oct 2005
- Last updated
- 22 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Kettenbach J, Helbich TH, Huber S, Zuna I, Dock W. Computer-assisted quantitative assessment of power Doppler US: effects of microbubble contrast agent in the differentiation of breast tumors. Eur J Radiol. 2005 Feb;53(2):238-44. doi: 10.1016/j.ejrad.2004.04.017.
PubMed 15664287Singh 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 15010893Martinez AM, Medina CJ, Bustos C, Hernandez JA. Assessment of breast lesions using Doppler with contrast agents. Eur J Gynaecol Oncol. 2003;24(6):527-30.
PubMed 14658595Cosgrove DO, Kedar RP, Bamber JC, al-Murrani B, Davey JB, Fisher C, McKinna JA, Svensson WE, Tohno E, Vagios E, et al. Breast diseases: color Doppler US in differential diagnosis. Radiology. 1993 Oct;189(1):99-104. doi: 10.1148/radiology.189.1.8372225.
PubMed 8372225
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions
- ClinicalTrials.gov ID
- NCT00243698
- Acronym / sponsor ID
- CT03-FT/SEN
- Conditions
- Breast Tumors
- Keywords
- Contrast-enhanced Ultrasound Sonography, Ultrasound Contrast agents, microbubbles, Breast tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- May 2004
- Study completion
- May 2007 (actual)
- First posted
- 24 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.
Ultrasound is a well-established imaging modality for the evaluation of breast disease.
The investigators' objective is to characterise the properties of an intravascular ultrasonographic contrast agent SonoVue (sulphur hexafluoride microbubbles) to improve the diagnostic value of the ultrasound examination in patients with different breast lesions.
The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the differentiation between benign and malignant lesions.
SonoVue® (sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging.
Contrast-enhanced ultrasound could provide a non-invasive technique to evaluate the morphology of breast tumour vascularity.
Detailed description
The main objective of the study is to evaluate the efficacy of SonoVue® to detect breast lesions and define specific microcirculation patterns in patients with four different type of breast lesions (enlarging fibroadenoma, suspect malignant nodules, microcalcification and large malignant nodules) in comparison with pathological specimens in terms of histology diagnosis and microvessel density evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Woman presenting with: enlarging fibroadenoma (less than 2 cm in diameter or woman over 40 years old with fibroadenoma less than 2 cm in diameter) or suspect malignant nodule (less than 2 cm in diameter) or a cluster of microcalcification or a malignant nodule (size greater than 3 cm) diagnosed with mammography and/or MRI and/or United States (US) examination performed within 1 month before the study.
- Woman scheduled for biopsy or surgery within 1 month from the examination.
Key exclusion criteria (11 listed)
- Patients who have already performed a biopsy on the lesion during investigation
- Any contraindication to perform a contrast-enhanced MRI examination for the patients presenting with a malignant nodule (size greater than 3 cm)
- Patients previously entered in this study or having received an investigational drug within 30 days prior to admission to this study
- Patients with any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or of achieving the study objectives (drug dependence, psychiatric disorders, dementia or other reasons)
- Pregnant or nursing female
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 |
|---|---|---|
| SonoVue (sulphur hexafluoride microbubbles)One contrast enhanced ultrasonography using sonovue / 4.8 ml per injection (maximum of 3 injections) | Drug | – |
Primary outcome
From contrast-enhanced ultrasound: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements.
Time frame: Inclusion period
2 secondary outcomes
Histology assessments: Microvessel density assessments to evaluate the total amount of microcirculation and the neoangiogenesis microcirculation present in the samples
Time frame: inclusion period
Off-line time-intensity curves from contrast-enhanced magnetic resonance imaging (MRI) images (malignant nodule greater than 3 cm in diameter only)
Time frame: inclusion period
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 22 Nov 2007.
- Background: PubMed 15664287Kettenbach J, Helbich TH, Huber S, Zuna I, Dock W. Computer-assisted quantitative assessment of power Doppler US: effects of microbubble contrast agent in the differentiation of breast tumors. Eur J Radiol. 2005 Feb;53(2):238-44. doi: 10.1016/j.ejrad.2004.04.017.
- 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 14658595Martinez AM, Medina CJ, Bustos C, Hernandez JA. Assessment of breast lesions using Doppler with contrast agents. Eur J Gynaecol Oncol. 2003;24(6):527-30.
- Results publication: PubMed 8372225Cosgrove DO, Kedar RP, Bamber JC, al-Murrani B, Davey JB, Fisher C, McKinna JA, Svensson WE, Tohno E, Vagios E, et al. Breast diseases: color Doppler US in differential diagnosis. Radiology. 1993 Oct;189(1):99-104. doi: 10.1148/radiology.189.1.8372225.
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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 SonoVue (sulphur hexafluoride microbubbles) in people with Breast Tumors, 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 3 inclusion and 11 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 22 Nov 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: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements. (time frame: Inclusion period). 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 NCT00243698, which also lists 5 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 22 Nov 2007.