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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Canada1 site
  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

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:

  1. A set of localizer images to position the breast in the MRI system.
  2. A series of 2D fast spin-echo T2 weighted images to cover the breast.
  3. An SPGR imaging sequence will be used to measure the T1 distribution over the breast for subsequent pharmacokinetic analysis as described by Chen[20].
  4. We will administer intravenous Gd-DTPA (0.1 mmol/kg) followed by a saline flush.
  5. 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:

  1. 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.
  2. We will calculate the T1 distribution throughout the breast based on the multi-angle T1 weighted SPGR sequence as per Cheng[20].
  3. This data will then be used to calculate the [Gd] for each voxel in the image sets.
  4. These will be used to estimate Ktrans and Ve from a two compartment tumour model[15].
  5. We will calculate these parameters over a region of interest defined by the enhancing tumour border.
  6. 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.

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.

  1. First posted3 Apr 2007 (estimated)
  2. Study startNov 2006
  3. Primary completionSep 2018
  4. Study completionSep 2018

Resources

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)
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

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.

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