Breast LesionNCT00582569
Breast MRI Spectroscopy, Department of Defense (DOD)
An observational study of Breast Lesion, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this new imaging method is to provide physicians with additional information not available with standard imaging methods. This includes information about the make up of different breast diseases. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Lesion
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to May 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Include women with lesions, > or = to 1 centimeter that will undergo a diagnostic MRI exam, an MRI guided biopsy, or an MRI guided needle localization, such as women with breast cancer or women with clinical and/or mammographic findings suspicious for breast masses. However, any known breast lesion, benign or malignant, will be appropriate for evaluation with MR spectroscopy.
Who may be able to join
- Patient needs to be ≥ or = to 18 years of age
- scheduled for diagnostic breast MRI examination or interventional procedure for a suspected or known breast lesion ≥ or = to 1 centimeter
Who cannot join
- Patients who would be normally excluded from undergoing an MRI examination include:
- Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
- Patients who are pregnant are excluded from participation of this study
- Patients who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety.
- Patients undergoing chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this new imaging method is to provide physicians with additional information not available with standard imaging methods. This includes information about the make up of different breast diseases. Using spectroscopy data, it may be possible to tell the difference between benign conditions of the breast from malignant tumors and provide more accurate information than can be obtained with regular MRI. Along with the MRI a new method of evaluating the images or pictures will be used. This new method is called spectroscopy and is used routinely on other parts of the body such as the prostate and brain. Pictures produced with this sequence look different than the regular MRI pictures. Performing spectroscopy on a 1.5T magnet adds another imaging sequence (another scan) to the routine MRI protocol, thus increasing exam time (extra 10-15 minutes). This study will enroll patients who are scheduled for a Magnetic Resonance Imaging (MRI) examination ordered by their primary physician.
Read the detailed description
Our aim is to perform MR Spectroscopy (MRS) on 150 patients at the end of their clinically indicated routine breast MRI guided biopsy and breast MRI guided needle localization examination using a software package from General Electric Medical Systems (Milwaukee,WI). This will add time to the routine examination but will not involve additional injections of contrast. We will analyze the spectroscopic data to determine if benign lesions can be reliably differentiated from malignant ones. The MR Spectroscopy (MRS) will be administered at Memorial Sloan Kettering Cancer Center, 1275 York Ave, NY,NY 10021.
- Conditions
- Breast Lesion
- Keywords
- Breast lesion, Spectroscopy, MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine if spectroscopy of the breast can be performed and can be functional in a clinical environment for breast lesions _> 1centimeter
Measured: conclusion of study
To see if MRS can differentiate ben vs mal breast tissue with adequate specificity & sensitivity to be useful in clinical management.
Measured: conclusion of study
Secondary outcomes (1)
if the data obtained can differentiate among various histologic subtypes of invasive and non-invasive breast cancers, and can be reliably analyzed and be useful to the final interpretation of the breast MRI examination.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startFeb 2006
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast LesionStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Sandra Brennan, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582569
- Sponsor's protocol ID
- 05-101
- Status last verified
- May 2013
- First submitted
- 21 Dec 2007
- Last updated
- 13 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast MRI Spectroscopy, Department of Defense (DOD)
- ClinicalTrials.gov ID
- NCT00582569
- Acronym / sponsor ID
- 05-101
- Conditions
- Breast Lesion
- Keywords
- Breast lesion, Spectroscopy, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Feb 2006
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Dec 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 purpose of this new imaging method is to provide physicians with additional information not available with standard imaging methods. This includes information about the make up of different breast diseases. Using spectroscopy data, it may be possible to tell the difference between benign conditions of the breast from malignant tumors and provide more accurate information than can be obtained with regular MRI. Along with the MRI a new method of evaluating the images or pictures will be used. This new method is called spectroscopy and is used routinely on other parts of the body such as the prostate and brain. Pictures produced with this sequence look different than the regular MRI pictures. Performing spectroscopy on a 1.5T magnet adds another imaging sequence (another scan) to the routine MRI protocol, thus increasing exam time (extra 10-15 minutes). This study will enroll patients who are scheduled for a Magnetic Resonance Imaging (MRI) examination ordered by their primary physician.
Detailed description
Our aim is to perform MR Spectroscopy (MRS) on 150 patients at the end of their clinically indicated routine breast MRI guided biopsy and breast MRI guided needle localization examination using a software package from General Electric Medical Systems (Milwaukee,WI). This will add time to the routine examination but will not involve additional injections of contrast. We will analyze the spectroscopic data to determine if benign lesions can be reliably differentiated from malignant ones. The MR Spectroscopy (MRS) will be administered at Memorial Sloan Kettering Cancer Center, 1275 York Ave, NY,NY 10021.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Include women with lesions, > or = to 1 centimeter that will undergo a diagnostic MRI exam, an MRI guided biopsy, or an MRI guided needle localization, such as women with breast cancer or women with clinical and/or mammographic findings suspicious for breast masses. However, any known breast lesion, benign or malignant, will be appropriate for evaluation with MR spectroscopy.
Key inclusion criteria (2 listed)
- Patient needs to be ≥ or = to 18 years of age
- scheduled for diagnostic breast MRI examination or interventional procedure for a suspected or known breast lesion ≥ or = to 1 centimeter
Key exclusion criteria (5 listed)
- Patients who would be normally excluded from undergoing an MRI examination include:
- Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
- Patients who are pregnant are excluded from participation of this study
- Patients who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety.
- Patients undergoing chemotherapy
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
to determine if spectroscopy of the breast can be performed and can be functional in a clinical environment for breast lesions _> 1centimeter
Time frame: conclusion of study
To see if MRS can differentiate ben vs mal breast tissue with adequate specificity & sensitivity to be useful in clinical management.
Time frame: conclusion of study
1 secondary outcome
if the data obtained can differentiate among various histologic subtypes of invasive and non-invasive breast cancers, and can be reliably analyzed and be useful to the final interpretation of the breast MRI examination.
Time frame: conclusion of study
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 May 2013.
- Memorial Sloan-Kettering Cancer Center websiteLink provided by the sponsor.
Related trials for Breast Lesion
Active, not recruiting
A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
Mammary Tumor, Nipple Discharge
Active, not recruitingObservational study
A Novel Fluorescent Ductal Needle for Localization and Sampling of High-risk Breast Micro Lesions
Mammary Tumor, Nipple Discharge
Active, not recruiting
Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants
Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation
Recruiting
Use of Magtrace Bracketing for Excision of Lesion and Sentinel Lymph Node Localization in Breast Conserving Surgery for Breast Cancer
Breast Cancer With Low to Intermediate HER2 Expression, Breast Cancer (Triple Negative Breast Cancer (TNBC))
Recruiting
ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions
Breast Cancer
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.
Sandra Brennan, MD principal investigator
Memorial Sloan Kettering 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 Lesion, run by Memorial Sloan Kettering 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 2 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 May 2013. 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?
to determine if spectroscopy of the breast can be performed and can be functional in a clinical environment for breast lesions _> 1centimeter (time frame: conclusion of study). The study lists 2 primary outcomes in all. 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 May 2013.