Ductal Carcinoma In-situNCT01391039
Diagnostic Study of Early Breast Cancer Using Ultrasound
A study testing Perflutren lipid microsphere in people with Ductal Carcinoma In-situ, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This is a pilot study designed to investigate new techniques to guide the appropriate diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and stiffness of the lesion may be prognostic factors that can guide the need for more or less extensive therapy or perhaps only imaging follow-up may… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ductal Carcinoma In-situ
- What is being tested?
- Perflutren lipid microsphere
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Jul 2015
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A woman with imaging signs suggesting a diagnosis of DCIS who is scheduled for ultrasound and a biopsy is eligible for the study.
- At least 18 years of age
Who cannot join
- Pregnant or possibly pregnant or breast feeding
- Unable to provide informed consent
- Drug or multiple allergies
- Known cardiac shunts
- Known cardiac or chronic pulmonary disease
- Hypersensitivity to perflutren
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer
This is a pilot study designed to investigate new techniques to guide the appropriate diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and stiffness of the lesion may be prognostic factors that can guide the need for more or less extensive therapy or perhaps only imaging follow-up may be needed.
Read the detailed description
Women who have imaging findings suggestive of DCIS, who are having breast ultrasound and who are candidates for surgery will be eligible. They will receive a contrast-enhanced breast ultrasound after the intravenous injection of a microbubble contrast agent which will show the microvascularity. A subset of women will also have ultrasound elastography performed of the abnormality to evaluate its stiffness.
- Conditions
- Ductal Carcinoma In-situ
- Being tested
- Perflutren lipid microsphere
- Keywords
- Ductal Carcinoma In-situ, Contrast Ultrasound, Microinvasion, Elastography
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perflutren lipid microsphereDrug
Also called Definity
Intravenous injection of 10 microL/kg once prior to ultrasound examination
| Study group | Role | What they receive |
|---|---|---|
| Contrast perfusion and elastography arm | Experimental | Intravenous injection of microbubble contrast agent and elastography Receives: Drug: Perflutren lipid microsphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.
Measured: The participant will be followed up till the results of the biopsy, an expected average of 3 months.
Secondary outcomes (1)
Measurement of transient shear wave elastography .
The quantitative intralesional measurement of shear wave modulus will be compared to the angiogenesis imaging and biomarkers.
Measured: The participant will be followed up till the results of the biopsy, an expected average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma In-situStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberta A Jong, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391039
- Sponsor's protocol ID
- RJ07062011
- Status last verified
- Nov 2015
- First submitted
- 15 Jun 2011
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer
- ClinicalTrials.gov ID
- NCT01391039
- Acronym / sponsor ID
- RJ07062011
- Conditions
- Ductal Carcinoma In-situ
- Keywords
- Ductal Carcinoma In-situ, Contrast Ultrasound, Microinvasion, Elastography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Jul 2011 (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 is a pilot study designed to investigate new techniques to guide the appropriate diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and stiffness of the lesion may be prognostic factors that can guide the need for more or less extensive therapy or perhaps only imaging follow-up may be needed.
Detailed description
Women who have imaging findings suggestive of DCIS, who are having breast ultrasound and who are candidates for surgery will be eligible. They will receive a contrast-enhanced breast ultrasound after the intravenous injection of a microbubble contrast agent which will show the microvascularity. A subset of women will also have ultrasound elastography performed of the abnormality to evaluate its stiffness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast perfusion and elastography arm | Experimental | Drug: Perflutren lipid microsphereIntravenous injection of microbubble contrast agent and elastography |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A woman with imaging signs suggesting a diagnosis of DCIS who is scheduled for ultrasound and a biopsy is eligible for the study.
- At least 18 years of age
Key exclusion criteria (6 listed)
- Pregnant or possibly pregnant or breast feeding
- Unable to provide informed consent
- Drug or multiple allergies
- Known cardiac shunts
- Known cardiac or chronic pulmonary disease
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 |
|---|---|---|
| Perflutren lipid microsphereAlso: DefinityIntravenous injection of 10 microL/kg once prior to ultrasound examination | Drug | Contrast perfusion and elastography arm |
Primary outcome
Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.
Time frame: The participant will be followed up till the results of the biopsy, an expected average of 3 months.
1 secondary outcome
Measurement of transient shear wave elastography .
Time frame: The participant will be followed up till the results of the biopsy, an expected average of 3 months.
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
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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.
Roberta A Jong, FRCPC principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perflutren lipid microsphere in people with Ductal Carcinoma In-situ, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 30 Nov 2015. 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 Canada. 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 was stopped early (reason given: Low recruitment). Results are not available in the source record.
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?
Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound. (time frame: The participant will be followed up till the results of the biopsy, an expected average of 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2015.