Breast CancerNCT02812589
Diffusion Tensor Breast MRI (DTI)
A study testing Diffusion tensor imaging (DTI) in Breast MRI in people with Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The breast MRI is used in the preoperative scenario to evaluate the extension of a newly diagnosed breast cancer and to screen the contralateral breast. The scan consists of a series of images taken after the use of intravascular contrast media that may detect areas of enhancement that look malignant, but are actually… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diffusion tensor imaging (DTI) in Breast MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Apr 2020
- 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
- Female of any race, ethnicity and lifetime risk.
- Eighteen years or older.
- Known recent diagnosis of a breast cancer and normal clinical breast exam of the contralateral side.
- Self-detected lump suspicious for breast cancer that it has not been biopsied yet.
Who cannot join
- Inability to understand the consent form
- Pregnant or nursing
- Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention
- Physically unable to lie down on her belly for at least 10 minutes.
- Have had benign needle biopsy of the breast performed within 3 months, or breast surgery within 1 year prior to MRI exam.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Princess Margaret Cancer Centre, University Health Network, 610 University Ave.
Toronto, Ontario, M5G 2M9
About this study
Official title: Improving the Specificity of Breast MRI Through Diffusion Tensor Breast MRI (DTI)
The breast MRI is used in the preoperative scenario to evaluate the extension of a newly diagnosed breast cancer and to screen the contralateral breast. The scan consists of a series of images taken after the use of intravascular contrast media that may detect areas of enhancement that look malignant, but are actually benign tissue, producing a false positive result. The investigators aim to evaluate a novel MRI sequence of images that does not use contrast, diffusion tensor imaging (DTI). Addition of DTI sequence does not add significantly to the time of standard breast MRI exam. This novel technique provides improved detection of tissue microstructure and is able to differentiate malignant from benign tumor. Hence, the investigators hypothesize that DTI may decrease the false positive rate when compared with standard dynamic contrast-enhanced (DCE) MRI.
- Conditions
- Breast Cancer
- Being tested
- Diffusion tensor imaging (DTI) in Breast MRI
- Keywords
- MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion tensor imaging (DTI) in Breast MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Diffusion tensor imaging (DTI) in breast MRI | Experimental | Not described Receives: Other: Diffusion tensor imaging (DTI) in Breast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anabel Scaranelo, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812589
- Sponsor's protocol ID
- 13-6856-CE
- Status last verified
- Apr 2021
- First submitted
- 4 May 2016
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Specificity of Breast MRI Through Diffusion Tensor Breast MRI (DTI)
- ClinicalTrials.gov ID
- NCT02812589
- Acronym / sponsor ID
- 13-6856-CE
- Conditions
- Breast Cancer
- Keywords
- MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 24 Jun 2016 (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.
The breast MRI is used in the preoperative scenario to evaluate the extension of a newly diagnosed breast cancer and to screen the contralateral breast. The scan consists of a series of images taken after the use of intravascular contrast media that may detect areas of enhancement that look malignant, but are actually benign tissue, producing a false positive result. The investigators aim to evaluate a novel MRI sequence of images that does not use contrast, diffusion tensor imaging (DTI). Addition of DTI sequence does not add significantly to the time of standard breast MRI exam. This novel technique provides improved detection of tissue microstructure and is able to differentiate malignant from benign tumor. Hence, the investigators hypothesize that DTI may decrease the false positive rate when compared with standard dynamic contrast-enhanced (DCE) MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diffusion tensor imaging (DTI) in breast MRI | Experimental | Other: Diffusion tensor imaging (DTI) in Breast MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female of any race, ethnicity and lifetime risk.
- Eighteen years or older.
- Known recent diagnosis of a breast cancer and normal clinical breast exam of the contralateral side.
- Self-detected lump suspicious for breast cancer that it has not been biopsied yet.
Key exclusion criteria (5 listed)
- Inability to understand the consent form
- Pregnant or nursing
- Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention
- Physically unable to lie down on her belly for at least 10 minutes.
- Have had benign needle biopsy of the breast performed within 3 months, or breast surgery within 1 year prior to MRI exam.
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 |
|---|---|---|
| Diffusion tensor imaging (DTI) in Breast MRI | Other | Diffusion tensor imaging (DTI) in breast MRI |
Primary outcome
Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates
Time frame: 3 years
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 13 Apr 2021.
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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.
Anabel Scaranelo, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion tensor imaging (DTI) in Breast MRI in people with Breast Cancer, run by University Health Network, Toronto 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 4 inclusion and 5 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 13 Apr 2021. 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 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?
Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates (time frame: 3 years). 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 13 Apr 2021.