Breast CancerNCT00610181
Magnetic Resonance Imaging in Patients With Breast Cancer
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn how often magnetic resonance imaging (MRI) of the breast locates additional areas of cancer in the breast of patients with lobular cancer as well as in the breasts of young breast cancer patients (less than age 40 years). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with invasive lobular cancer of the breast.
Who may be able to join
- Patients with pure invasive lobular carcinoma or mixed invasive ductal-lobular carcinoma with the ductal component not greater that 25% OR patients under the age of 40 at diagnosis, irrespective of tumor histology
- For women with invasive lobular carcinoma, if the pathology report from the diagnostic biopsy states that they have "predominantly" lobular histology or lobular cancer with "focal" areas/nests of ductal carcinoma, these cases will automatically be assumed to have at least 75% lobular component.
- Women with multifocal or multicentric breast cancer are eligible if any one of the biopsy confirmed tumors meets the histologic designations outlined in Inclusion criteria #1 and #2 above.
- Must be able to complete the MR examination within 30 days of mammography and ultrasound of the breast.
- Age >18 years
- Surgery planned at MDACC
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- Creatinine and glomerular filtration rate measured or calculated within 2 weeks of MRI date
Who cannot join
- Patients receiving neoadjuvant chemotherapy
- Patients with pacemakers
- Patients with severe claustrophobia
- Obese patients exceeding the equipment weight limits and/or the circumference of the MRI portal
- Interval between MRI and conventional locoregional staging studies (mammography/breast US) greater than 30 days.
- Known allergy to gadolinium
- Patients with clips/prostheses/implanted devices that are not MRI compatible
- Compromised renal function, with a measured or calculated glomerular filtration rate of less than 60 ml/min/1.73m^2.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Magnetic Resonance Imaging (MRI) for Preoperative Staging of Patients With Invasive Lobular Carcinoma of the Breast
The goal of this clinical research study is to learn how often magnetic resonance imaging (MRI) of the breast locates additional areas of cancer in the breast of patients with lobular cancer as well as in the breasts of young breast cancer patients (less than age 40 years). Researchers also hope to learn how often the results of the MRI changes the type of surgical treatment that is recommended and understand the costs associated with using MRI in the diagnostic process. Researchers also want to use a different way of looking at the MRI scans to learn if they can more easily learn the difference between a cyst and a tumor.
Read the detailed description
At MD Anderson, patients with breast cancer routinely have mammograms and ultrasounds to measure the size and extent of cancer.
MRI of the breast is a technology that is better than mammograms and ultrasounds at locating cancer. Although MRI may locate more areas of cancer, it can sometimes falsely identify normal areas of the breast as cancerous.
Unlike ductal cancer of the breast (the most common type of breast cancer), lobular cancer is more difficult to see on mammograms and ultrasounds. Therefore, patients with lobular cancer of the breast may be best suited for MRI of the breast in order to more accurately determine the extent of the cancer. In addition, in young women, because the breast tissue is very dense, all types of breast tumors are harder to detect with mammogram and ultrasound and may be better seen with MRI.
A correct measurement of the size and extent of the cancer is important because this affects the recommendation for the type of surgery a patient may have.
Study Procedures:
If you agree to take part in this study, you will have an MRI of both breasts.
For the MRI, part or all of the body will be passed into a long, narrow tube scanner, which is open at both ends.
The MRI images will be compared with the images from your standard of care mammogram and ultrasound images. If the MRI shows abnormalities not seen on the mammogram or ultrasound and your doctor thinks it is necessary, you may have additional testing and/or a tumor biopsy. This is part of your standard of care.
The results of this additional MRI testing will be used by your surgeon to guide his/her recommendations for your surgery.
Information like your age, diagnosis, and results of your testing will be collected as part of the data analysis for this study.
No identifying information will be sent outside of MD Anderson. Your information will be stored on a password-protected computer. Information may be kept for up to 5 years after the study ends.
This is an investigational study. The investigational part of this study is the comparison of the outcome of MRI images to mammogram and ultrasound images in determining appropriate surgical therapy.
Up to 170 patients will be take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- MRI
- Keywords
- Breast Cancer, Breast Carcinoma, Invasive Lobular Cancer, Mixed Invasive Ductal-lobular Carcinoma, Magnetic Resonance Imaging, 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.
MRIProcedure or surgery
MRI of both breasts, results used for surgery, then MRI repeated in 1 year as part of routine follow-up after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Breast MRI | Magnetic resonance imaging (MRI) of breast for patients with invasive lobular carcinoma of the breast. Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in surgical management of patients with invasive lobular carcinoma of the breast and young breast cancer patients as a result of preoperative breast MRI
Measured: 3 years (# of times MRI changes type of surgical treatment recommended)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2015
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 M.D. Anderson Cancer CenterThe 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Bedrosian, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610181
- Sponsor's protocol ID
- 2007-0736
- Status last verified
- Jun 2015
- First submitted
- 24 Jan 2008
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging (MRI) for Preoperative Staging of Patients With Invasive Lobular Carcinoma of the Breast
- ClinicalTrials.gov ID
- NCT00610181
- Acronym / sponsor ID
- 2007-0736
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast Carcinoma, Invasive Lobular Cancer, Mixed Invasive Ductal-lobular Carcinoma, Magnetic Resonance Imaging, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2015 (actual)
- First posted
- 7 Feb 2008 (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 goal of this clinical research study is to learn how often magnetic resonance imaging (MRI) of the breast locates additional areas of cancer in the breast of patients with lobular cancer as well as in the breasts of young breast cancer patients (less than age 40 years). Researchers also hope to learn how often the results of the MRI changes the type of surgical treatment that is recommended and understand the costs associated with using MRI in the diagnostic process. Researchers also want to use a different way of looking at the MRI scans to learn if they can more easily learn the difference between a cyst and a tumor.
Detailed description
At MD Anderson, patients with breast cancer routinely have mammograms and ultrasounds to measure the size and extent of cancer.
MRI of the breast is a technology that is better than mammograms and ultrasounds at locating cancer. Although MRI may locate more areas of cancer, it can sometimes falsely identify normal areas of the breast as cancerous.
Unlike ductal cancer of the breast (the most common type of breast cancer), lobular cancer is more difficult to see on mammograms and ultrasounds. Therefore, patients with lobular cancer of the breast may be best suited for MRI of the breast in order to more accurately determine the extent of the cancer. In addition, in young women, because the breast tissue is very dense, all types of breast tumors are harder to detect with mammogram and ultrasound and may be better seen with MRI.
A correct measurement of the size and extent of the cancer is important because this affects the recommendation for the type of surgery a patient may have.
Study Procedures:
If you agree to take part in this study, you will have an MRI of both breasts.
For the MRI, part or all of the body will be passed into a long, narrow tube scanner, which is open at both ends.
The MRI images will be compared with the images from your standard of care mammogram and ultrasound images. If the MRI shows abnormalities not seen on the mammogram or ultrasound and your doctor thinks it is necessary, you may have additional testing and/or a tumor biopsy. This is part of your standard of care.
The results of this additional MRI testing will be used by your surgeon to guide his/her recommendations for your surgery.
Information like your age, diagnosis, and results of your testing will be collected as part of the data analysis for this study.
No identifying information will be sent outside of MD Anderson. Your information will be stored on a password-protected computer. Information may be kept for up to 5 years after the study ends.
This is an investigational study. The investigational part of this study is the comparison of the outcome of MRI images to mammogram and ultrasound images in determining appropriate surgical therapy.
Up to 170 patients will be take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast MRI | – | Procedure: MRIMagnetic resonance imaging (MRI) of breast for patients with invasive lobular carcinoma of the breast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with invasive lobular cancer of the breast.
Key inclusion criteria (8 listed)
- Patients with pure invasive lobular carcinoma or mixed invasive ductal-lobular carcinoma with the ductal component not greater that 25% OR patients under the age of 40 at diagnosis, irrespective of tumor histology
- For women with invasive lobular carcinoma, if the pathology report from the diagnostic biopsy states that they have "predominantly" lobular histology or lobular cancer with "focal" areas/nests of ductal carcinoma, these cases will automatically be assumed to have at least 75% lobular component.
- Women with multifocal or multicentric breast cancer are eligible if any one of the biopsy confirmed tumors meets the histologic designations outlined in Inclusion criteria #1 and #2 above.
- Must be able to complete the MR examination within 30 days of mammography and ultrasound of the breast.
- Age >18 years
Key exclusion criteria (8 listed)
- Patients receiving neoadjuvant chemotherapy
- Patients with pacemakers
- Patients with severe claustrophobia
- Obese patients exceeding the equipment weight limits and/or the circumference of the MRI portal
- Interval between MRI and conventional locoregional staging studies (mammography/breast US) greater than 30 days.
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 |
|---|---|---|
| MRIMRI of both breasts, results used for surgery, then MRI repeated in 1 year as part of routine follow-up after surgery. | Procedure or surgery | Breast MRI |
Primary outcome
Change in surgical management of patients with invasive lobular carcinoma of the breast and young breast cancer patients as a result of preoperative breast MRI
Time frame: 3 years (# of times MRI changes type of surgical treatment recommended)
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 1 Jul 2015.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Isabelle Bedrosian, MD principal investigator
M.D. Anderson Cancer Center
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 Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 8 inclusion and 8 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 1 Jul 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 United States. 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?
Change in surgical management of patients with invasive lobular carcinoma of the breast and young breast cancer patients as a result of preoperative breast MRI (time frame: 3 years (# of times MRI changes type of surgical treatment recommended)). 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 1 Jul 2015.