Breast CancerNCT03158441
DTi Diffusion Findings in Breast MRI Screening and Diagnostic
An observational study of Breast Cancer, run by Rabin Medical Center.
Trial summary
Introduction The most common breast cancer originates within the breast milk ducts, and is called ductal carcinoma. After the stage where the cancer is found only within the ducts, it invades the breast tissue beyond the ducts, and becomes invasive cancer (Infiltrating Duct Carcinoma). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast MRI
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Jul 2025
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The patients enrolled for the study will be women scheduled for breast MRI due to high risk screening or pretreatment evaluation. The patients will fill in a form regarding: age, hormonal status, risk factors, prior breast surgery or treatment (a form which is routinely filled out in our institution). They will then undergo a breast MRI scan, using the routine protocol in our institution. This will be directly followed by a DTI sequence, which takes about 10 minutes in addition to the regular examination. The DTI sequence is routinely used in other imaging institutions, as part of the breast MRI protocol.
Who may be able to join
- all patients undergoing breast MRI
Who cannot join
- general contraindication to MRI -
About this study
Introduction The most common breast cancer originates within the breast milk ducts, and is called ductal carcinoma. After the stage where the cancer is found only within the ducts, it invades the breast tissue beyond the ducts, and becomes invasive cancer (Infiltrating Duct Carcinoma). Breast cancer located within the ducts is called intra ductal carcinoma in situ- DCIS. DCIS is the developing cancer and usually does not metastasize. Another type of breast cancer originates within the breast lobules and is call lobular carcinoma.
Recently at the Weizmann Institute, Prof. Hadassa Degani and her group developed and imaging technique using breast MRI. This technique allows to map the three-dimensional structure of the milk ducts in the breast. The method is based on measuring the random movement (Brownian motion) of water molecules (diffusion) in different directions in the breast tissue, collecting diffusion images by using magnetic field gradients in different directions, allowing imaging of Diffusion tensor Imaging -DTI. Movement of water molecules within a unified solution is usually random and uniform in all directions, but the internal structures in biological systems (such as cells, pipelines, fiber) restrict the movement of water in certain directions. The DTI method exploits this feature by measuring the diffusion in various directions, thus enabling calculating images of biological structures [1]. This method was proved to be effective in mapping the brain's white matter fibers and is used routinely in clinical tests used to monitor neurological injuries [2-4]. This method was used for milk ducts mapping within breast tissue at the Weizmann Institute. The system that was developed at the Weizmann Institute, showed that the movement of water molecules along the milk ducts is faster than their movement across the ducts and therefore it was possible using this method to map the breast ductal system. Also this method showed that it is possible to detect and diagnose malignant changes within breast and to distinguish them from normal tissue and benign tumors using DTI. Changes in cell density and arrangement causes changes in the directional diffusion coefficients and the differences between them [5-9] Research Plan Summary A prospective preliminary study to evaluate the correlation between the DTI analysis of breast MRI and the results of conventional contrast enhanced breast MRI.
Read more
The patients enrolled for the study will be women scheduled for breast MRI due to high risk screening or pretreatment evaluation. The patients will fill in a form regarding: age, hormonal status, risk factors, prior breast surgery or treatment (a form which is routinely filled out in our institution). They will then undergo a breast MRI scan, using the routine protocol in our institution. This will be directly followed by a DTI sequence, which takes about 10 minutes in addition to the regular examination. The DTI sequence is routinely used in other imaging institutions, as part of the breast MRI protocol.
The exams will be read on our regular work stations, and in addition will be analyzed by software developed at the Weizmann Institute. Both interpretations will then be compared to each other and to clinical and pathological data
- Conditions
- Breast Cancer
- Being tested
- Breast MRI
- Keywords
- MRI, Diffusion, DTI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast MRIDiagnostic test
comparison of DTI to dynamic MRI
| Study group | Role | What they receive |
|---|---|---|
| cases | The patients enrolled for the study will be women scheduled for breast MRI due to high risk screening or pretreatment evaluation. The patients will fill in a form regarding: age, hormonal status, risk factors, prior breast surgery or treatment (a form which is routinely filled out in our institution). They will then undergo a breast MRI scan, using the routine protocol in our institution. This will be directly followed by a DTI sequence, which takes about 10 minutes in addition to the regular examination. The DTI sequence is routinely used in other imaging institutions, as part of the breast MRI protocol. Receives: Diagnostic Test: Breast MRI | |
| control | same patients , dynamic scan Receives: Diagnostic Test: Breast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
DTI results as compre to dynamic scan results
colored scaling of DTI ranging from green to yellow and red as compare dynamic scan
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 Jul 2017
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2025 (estimated)
Why it stopped: for technical and funding issues
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahuva Grubstein, Rabin Medical Center
- Investigators
- Ahuva Grubstein, MD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158441
- Sponsor's protocol ID
- 0425-16-RMC
- Status last verified
- May 2017
- First submitted
- 16 May 2017
- Last updated
- 23 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DTi Diffusion Findings in Breast MRI Screening and Diagnostic
- ClinicalTrials.gov ID
- NCT03158441
- Acronym / sponsor ID
- 0425-16-RMC
- Conditions
- Breast Cancer
- Keywords
- MRI, Diffusion, DTI
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: for technical and funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 18 May 2017 (actual)
- 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.
Introduction The most common breast cancer originates within the breast milk ducts, and is called ductal carcinoma. After the stage where the cancer is found only within the ducts, it invades the breast tissue beyond the ducts, and becomes invasive cancer (Infiltrating Duct Carcinoma). Breast cancer located within the ducts is called intra ductal carcinoma in situ- DCIS. DCIS is the developing cancer and usually does not metastasize. Another type of breast cancer originates within the breast lobules and is call lobular carcinoma.
Recently at the Weizmann Institute, Prof. Hadassa Degani and her group developed and imaging technique using breast MRI. This technique allows to map the three-dimensional structure of the milk ducts in the breast. The method is based on measuring the random movement (Brownian motion) of water molecules (diffusion) in different directions in the breast tissue, collecting diffusion images by using magnetic field gradients in different directions, allowing imaging of Diffusion tensor Imaging -DTI. Movement of water molecules within a unified solution is usually random and uniform in all directions, but the internal structures in biological systems (such as cells, pipelines, fiber) restrict the movement of water in certain directions. The DTI method exploits this feature by measuring the diffusion in various directions, thus enabling calculating images of biological structures [1]. This method was proved to be effective in mapping the brain's white matter fibers and is used routinely in clinical tests used to monitor neurological injuries [2-4]. This method was used for milk ducts mapping within breast tissue at the Weizmann Institute. The system that was developed at the Weizmann Institute, showed that the movement of water molecules along the milk ducts is faster than their movement across the ducts and therefore it was possible using this method to map the breast ductal system. Also this method showed that it is possible to detect and diagnose malignant changes within breast and to distinguish them from normal tissue and benign tumors using DTI. Changes in cell density and arrangement causes changes in the directional diffusion coefficients and the differences between them [5-9] Research Plan Summary A prospective preliminary study to evaluate the correlation between the DTI analysis of breast MRI and the results of conventional contrast enhanced breast MRI.
The patients enrolled for the study will be women scheduled for breast MRI due to high risk screening or pretreatment evaluation. The patients will fill in a form regarding: age, hormonal status, risk factors, prior breast surgery or treatment (a form which is routinely filled out in our institution). They will then undergo a breast MRI scan, using the routine protocol in our institution. This will be directly followed by a DTI sequence, which takes about 10 minutes in addition to the regular examination. The DTI sequence is routinely used in other imaging institutions, as part of the breast MRI protocol.
The exams will be read on our regular work stations, and in addition will be analyzed by software developed at the Weizmann Institute. Both interpretations will then be compared to each other and to clinical and pathological data
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Diagnostic Test: Breast MRIThe patients enrolled for the study will be women scheduled for breast MRI due to high risk screening or pretreatment evaluation. The patients will fill in a form regarding: age, hormonal status, risk factors, prior breast surgery or treatment (a form which is routinely filled out in our institution). They will then undergo a breast MRI scan, using the routine protocol in our institution. This will be directly followed by a DTI sequence, which takes about 10 minutes in addition to the regular examination. The DTI sequence is routinely used in other imaging institutions, as part of the breast MRI protocol. |
| control | – | Diagnostic Test: Breast MRIsame patients , dynamic scan |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The patients enrolled for the study will be women scheduled for breast MRI due to high risk screening or pretreatment evaluation. The patients will fill in a form regarding: age, hormonal status, risk factors, prior breast surgery or treatment (a form which is routinely filled out in our institution). They will then undergo a breast MRI scan, using the routine protocol in our institution. This will be directly followed by a DTI sequence, which takes about 10 minutes in addition to the regular examination. The DTI sequence is routinely used in other imaging institutions, as part of the breast MRI protocol.
Key inclusion criteria (1 listed)
- all patients undergoing breast MRI
Key exclusion criteria (1 listed)
- general contraindication to MRI -
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 |
|---|---|---|
| Breast MRIcomparison of DTI to dynamic MRI | Diagnostic test | cases, control |
Primary outcome
DTI results as compre to dynamic scan results
Time frame: 1 year
colored scaling of DTI ranging from green to yellow and red as compare dynamic scan
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Ahuva Grubstein, MD principal investigator
Tel Aviv University
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Rabin Medical Center.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
DTI results as compre to dynamic scan results (time frame: 1 year). 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 23 Apr 2019.