Suspicion of, or Known Breast CancerNCT00577915
Breast MRI Spectroscopy
A study testing Radiology/MRI scan in people with Suspicion of, or Known Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to provide physicians with additional information not available with standard imaging methods for breast disease. As part of the MRI examination ordered by your physician, a new method of analyzing the images or pictures will be used. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Suspicion of, or Known Breast Cancer
- What is being tested?
- Radiology/MRI scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Jun 2016
- Phase
- Interventional
- 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
Who may be able to join
- Scheduled for diagnostic breast MRI examination or interventional procedure for a known or suspected breast lesion
Who cannot join
- Patients who would be normally excluded from undergoing an MRI examination:
- Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
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 study is to provide physicians with additional information not available with standard imaging methods for breast disease.
As part of the MRI examination ordered by your physician, a new method of analyzing 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 may look slightly different than the regular MRI pictures. Using spectroscopy data, it may be possible to distinguish benign conditions of the breast from malignant tumors and provide more precise information than can be obtained with regular MRI.
Read the detailed description
Our aim is to perform MR Spectroscopy (MRS) on 150 evaluable patients at the end of their routine breast MRI 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.
- Conditions
- Suspicion of, or Known Breast Cancer
- Being tested
- Radiology/MRI scan
- Keywords
- Breast cancer, MRI spectroscopy, Diagnostic radiology
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiology/MRI scanOther
MRI spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Breast MR Spectroscopy | Experimental | Conventional images will be taken with standard pulse sequences. These images will be used for the diagnostic examination for which the patient will have been scheduled. Following the diagnostic study, a pulse sequence designed to obtain spectroscopy data will be used.This will be used on the existing magnets 1.5T and 3T. Memorial Sloan-Kettering Cancer Center has 1.5T and 3T magnets. The patient will have only one injection of contrast (gadolinium-DTPA) for the initial diagnostic study. No additional contrast will be administered. The additional sequence should take about 10 minutes, depending on breast size. Receives: Other: Radiology/MRI scan |
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.
Measured: 12 months
Secondary outcomes (1)
To determine if the data obtained can be reliably analyzed and useful to the final interpretation of the breast MRI examination.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startMay 2003
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspicion of, or Known Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Brennan, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577915
- Sponsor's protocol ID
- 03-037
- Status last verified
- Nov 2016
- First submitted
- 18 Dec 2007
- Last updated
- 29 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast MRI Spectroscopy
- ClinicalTrials.gov ID
- NCT00577915
- Acronym / sponsor ID
- 03-037
- Conditions
- Suspicion of, or Known Breast Cancer
- Keywords
- Breast cancer, MRI spectroscopy, Diagnostic radiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 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 study is to provide physicians with additional information not available with standard imaging methods for breast disease.
As part of the MRI examination ordered by your physician, a new method of analyzing 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 may look slightly different than the regular MRI pictures. Using spectroscopy data, it may be possible to distinguish benign conditions of the breast from malignant tumors and provide more precise information than can be obtained with regular MRI.
Detailed description
Our aim is to perform MR Spectroscopy (MRS) on 150 evaluable patients at the end of their routine breast MRI 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast MR Spectroscopy | Experimental | Other: Radiology/MRI scanConventional images will be taken with standard pulse sequences. These images will be used for the diagnostic examination for which the patient will have been scheduled. Following the diagnostic study, a pulse sequence designed to obtain spectroscopy data will be used.This will be used on the existing magnets 1.5T and 3T. Memorial Sloan-Kettering Cancer Center has 1.5T and 3T magnets. The patient will have only one injection of contrast (gadolinium-DTPA) for the initial diagnostic study. No additional contrast will be administered. The additional sequence should take about 10 minutes, depending on breast size. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for diagnostic breast MRI examination or interventional procedure for a known or suspected breast lesion
Key exclusion criteria (2 listed)
- Patients who would be normally excluded from undergoing an MRI examination:
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 |
|---|---|---|
| Radiology/MRI scanMRI spectroscopy | Other | Breast MR Spectroscopy |
Primary outcome
To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment.
Time frame: 12 months
1 secondary outcome
To determine if the data obtained can be reliably analyzed and useful to the final interpretation of the breast MRI examination.
Time frame: 12 months
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 29 Nov 2016.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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?
A study testing Radiology/MRI scan in people with Suspicion of, or Known Breast Cancer, 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 1 inclusion and 2 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 29 Nov 2016. 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. (time frame: 12 months). 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 29 Nov 2016.