Locally Advanced Breast CancerNCT00455273
Dynamic Breast MRI in Assessing Locally Advanced Breast Cancer
An observational study of Locally Advanced Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The project outline which follows is a pilot investigation aimed at improving MRI parameters in DCE-MRI to optimize the detection of treatment responses in LABC. The primary objective is to define the activity of neoadjuvant chemotherapy in patients with biopsy proven operable breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Locally Advanced Breast Cancer
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2006to Sep 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who are receiving neoadjuvant chemotherapy or neoadjuvant chemo-radiotherapy for locally-advanced breast cancer.
Who may be able to join
- Women with locally Advanced Breast Cancer
Who cannot join
- Contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
The project outline which follows is a pilot investigation aimed at improving MRI parameters in DCE-MRI to optimize the detection of treatment responses in LABC.
The primary objective is to define the activity of neoadjuvant chemotherapy in patients with biopsy proven operable breast cancer. Secondary objectives include evaluating a new MRI pulse sequence to optimize DCE-MRI of LABC responses.
Read the detailed description
We will conduct DCE-MRI prior and after the completion of neoadjuvant chemotherapy to monitor response to therapy. This will be done in a pilot study of 5 patients enrolled at Sunnybrook Health Sciences Centre recruited through the project investigation. The patients will be scanned on the research General Electric, 1.5 Tesla imaging system (version 12). We will use specially designed coils which we have developed and optimized for breast MR imaging. These allow modest compression of the breast in a medial-lateral direction and serves to bring surface coils as close the breast as possible to both immobilize the breast and achieve maximum coil couple and image signal/noise.
The dynamic data needs to cover the entire breast, so we will use a fast T1 weighted, dynamic breast MRI sequence [18, 19]. This will allow us to collect dynamic MRI data to cover the tumour volume with a temporal resolution of at least 20 seconds per data set and adequate spatial resolution (~1mm) to ensure adequate definition of the tumour boundary. The pulse sequence will be a spoiled gradient recalled sequence (SPGR) with imaging parameters TR/TE=8.2ms and min-TE. The image will be collected with a field of view of 16-20 cm depending on the patient breast size. Imaging resolution will be approximately 1 mm in-plane and 4-5 mm in slice thickness. The specific sequence of the imaging study is as follows:
- A set of localizer images to position the breast in the MRI system.
- A series of 2D fast spin-echo T2 weighted images to cover the breast.
- An SPGR imaging sequence will be used to measure the T1 distribution over the breast for subsequent pharmacokinetic analysis as described by Chen[20].
- We will administer intravenous Gd-DTPA (0.1 mmol/kg) followed by a saline flush.
- Immediate prior to the Gd injection, we will start a continuous application of the dynamic MRI sequence to the involved breast collecting data for 10 minutes post injection of Gd-DTPA. The imaging will precede the Gd injection by approximately 2 minutes to provide adequate imaging data to serve as the non contrast-enhanced baseline data.
3.2 - Data Analysis:
These images will be used to assess the tumour as follows:
- The simplest measurement will be that of tumour size as determined by the region of enhancement seen between prior to contrast enhancement versus that seen throughout the 10 minutes period post injection.
- We will calculate the T1 distribution throughout the breast based on the multi-angle T1 weighted SPGR sequence as per Cheng[20].
- This data will then be used to calculate the [Gd] for each voxel in the image sets.
- These will be used to estimate Ktrans and Ve from a two compartment tumour model[15].
- We will calculate these parameters over a region of interest defined by the enhancing tumour border.
- We will estimate these parameters on a pixel basis to study tumour heterogeneity over the tumour as characterized by the statistics of the parameters Ktrans and Ve.
The tumour volume measurements will be done by Dr. P. Causer of the Department of Medical Imaging of Sunnybrook Health Sciences Centre. The analysis of the dynamic data will be done by Dr. Plewes' group and Dr. A Martel of Imaging Research in conjunction with Dr. Causer. The final result, will be measures of the changes in tumour volume before and after neoadjuvant chemotherapy. In addition, we will have information regarding the distribution of Ktrans and Ve over the regions of the tumour and their variation before and after therapy.
- Conditions
- Locally Advanced Breast Cancer
- Keywords
- Breast Cancer, DCE MRI
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startNov 2006
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre
- Investigators
- a, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455273
- Sponsor's protocol ID
- 237-2006
- Status last verified
- Sep 2019
- First submitted
- 30 Mar 2007
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Breast MRI in Assessing Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00455273
- Acronym / sponsor ID
- 237-2006
- Conditions
- Locally Advanced Breast Cancer
- Keywords
- Breast Cancer, DCE MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 3 Apr 2007 (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 project outline which follows is a pilot investigation aimed at improving MRI parameters in DCE-MRI to optimize the detection of treatment responses in LABC.
The primary objective is to define the activity of neoadjuvant chemotherapy in patients with biopsy proven operable breast cancer. Secondary objectives include evaluating a new MRI pulse sequence to optimize DCE-MRI of LABC responses.
Detailed description
We will conduct DCE-MRI prior and after the completion of neoadjuvant chemotherapy to monitor response to therapy. This will be done in a pilot study of 5 patients enrolled at Sunnybrook Health Sciences Centre recruited through the project investigation. The patients will be scanned on the research General Electric, 1.5 Tesla imaging system (version 12). We will use specially designed coils which we have developed and optimized for breast MR imaging. These allow modest compression of the breast in a medial-lateral direction and serves to bring surface coils as close the breast as possible to both immobilize the breast and achieve maximum coil couple and image signal/noise.
The dynamic data needs to cover the entire breast, so we will use a fast T1 weighted, dynamic breast MRI sequence [18, 19]. This will allow us to collect dynamic MRI data to cover the tumour volume with a temporal resolution of at least 20 seconds per data set and adequate spatial resolution (~1mm) to ensure adequate definition of the tumour boundary. The pulse sequence will be a spoiled gradient recalled sequence (SPGR) with imaging parameters TR/TE=8.2ms and min-TE. The image will be collected with a field of view of 16-20 cm depending on the patient breast size. Imaging resolution will be approximately 1 mm in-plane and 4-5 mm in slice thickness. The specific sequence of the imaging study is as follows:
- A set of localizer images to position the breast in the MRI system.
- A series of 2D fast spin-echo T2 weighted images to cover the breast.
- An SPGR imaging sequence will be used to measure the T1 distribution over the breast for subsequent pharmacokinetic analysis as described by Chen[20].
- We will administer intravenous Gd-DTPA (0.1 mmol/kg) followed by a saline flush.
- Immediate prior to the Gd injection, we will start a continuous application of the dynamic MRI sequence to the involved breast collecting data for 10 minutes post injection of Gd-DTPA. The imaging will precede the Gd injection by approximately 2 minutes to provide adequate imaging data to serve as the non contrast-enhanced baseline data.
3.2 - Data Analysis:
These images will be used to assess the tumour as follows:
- The simplest measurement will be that of tumour size as determined by the region of enhancement seen between prior to contrast enhancement versus that seen throughout the 10 minutes period post injection.
- We will calculate the T1 distribution throughout the breast based on the multi-angle T1 weighted SPGR sequence as per Cheng[20].
- This data will then be used to calculate the [Gd] for each voxel in the image sets.
- These will be used to estimate Ktrans and Ve from a two compartment tumour model[15].
- We will calculate these parameters over a region of interest defined by the enhancing tumour border.
- We will estimate these parameters on a pixel basis to study tumour heterogeneity over the tumour as characterized by the statistics of the parameters Ktrans and Ve.
The tumour volume measurements will be done by Dr. P. Causer of the Department of Medical Imaging of Sunnybrook Health Sciences Centre. The analysis of the dynamic data will be done by Dr. Plewes' group and Dr. A Martel of Imaging Research in conjunction with Dr. Causer. The final result, will be measures of the changes in tumour volume before and after neoadjuvant chemotherapy. In addition, we will have information regarding the distribution of Ktrans and Ve over the regions of the tumour and their variation before and after therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who are receiving neoadjuvant chemotherapy or neoadjuvant chemo-radiotherapy for locally-advanced breast cancer.
Key inclusion criteria (1 listed)
- Women with locally Advanced Breast Cancer
Key exclusion criteria (1 listed)
- Contraindications 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.
Primary outcome
Not reported in the source record.
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 23 Sep 2019.
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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.
a 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?
An observational study of Locally Advanced Breast Cancer, 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 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: finished, as of the sponsor's last update on 23 Sep 2019. 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.
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 Sep 2019.