Breast CancerNCT00582764
Quantitative Dynamic Contrast Enhanced Breast MRI
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see if dynamic contrast enhanced (DCE) MRI imaging makes it possible to distinguish benign conditions of the breast from malignant tumors and provide better information than can be obtained with regular MRI. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- perform dynamic contrast enhanced (DCE) MRI
- Type of treatment
- Injection or infusion
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jul 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be selected at the time of the MRI interventional procedure by the radiologist who is protocoling the MRI examinations and who is an investigator on this protocol. Any known breast lesion, benign or malignant, will be appropriate for evaluation with DCE MRI. Pathology results will be obtained for each patient as a result of surgery or MRI guided biopsy, allowing correlation between the pathology and DCE MRI data.
Who may be able to join
- scheduled for breast MRI interventional procedure for a known 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.
- patients who are unable to cooperate for an MRI, and/or have known reaction to gadolinium contrast agent.
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 see if dynamic contrast enhanced (DCE) MRI imaging makes it possible to distinguish benign conditions of the breast from malignant tumors and provide better information than can be obtained with regular MRI. DCE MRI uses a new way of collecting and analyzing the images or pictures which provides doctors extra information not available with standard imaging methods. This includes information about the blood vessels of different breast diseases. Pictures produced this way look just like the regular MRI pictures. The DCE MRI adds another imaging sequence (another scan) to the MRI examination ordered by your physician to evaluate your breast lesion, thus increasing the exam time (extra 10 min). The information gained from doing the new test, the DCE MRI, will not be used in your treatment and will not affect the type of care you receive for your breast lesions.
Read the detailed description
Our aim is to perform dynamic contrast enhanced (DCE) MRI on 150 patients during their routine breast MRI examination at MSKCC. This will add extra 10 min scanning time to the routine examination. High resolution (submillimeter) parametric maps of pathophysiologic quantities, such as tumor vessel permeability, tumor perfusion, extracellular extravascular volume fraction, will be generated from the DCE MRI data. These results will be correlated with pathology to determine new pharmacokinetic threshold so that the negative predictive value for benign lesions is close to 100%. The improvement in diagnostic specificity may help to reduce unnecessary biopsies in the future.
- Conditions
- Breast Cancer
- Being tested
- perform dynamic contrast enhanced (DCE) MRI
- Keywords
- Breast Lesion, Lesion, Breast, Cancer, 05-091
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perform dynamic contrast enhanced (DCE) MRIOther
With an IV catheter in place, the patient will lie prone on the MRI scanner table with the breasts positioned in the commercial breast coil and then be moved feet first to the center of the MRI scanner. The only difference introduced by the addition of DCE MRI is that before the patient is moved into the scanner for the first time, the IV catheter will be hooked up with a programmable power injector (Medrad, Indianola, PA) which is loaded with Gd contrast and saline. The contrast injection and saline flush will be delivered by the injector while the patient is inside the scanner and the DCE MRI data collection is in process. The Gd contrast dose used for DCE MRI is the same as for clinical MRI: 0.1 mmol/kg. The injection speed of 2 mL/sec is safe and similar to that of manual injection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Any patient undergoing MRI guided preoperative needle localization or MRI guided biopsy of the breast. Receives: Other: perform dynamic contrast enhanced (DCE) MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether the new quantitative MRI method can discriminate between malignant and nonmalignant breast lesions among the lesions seen in conventional MRI.
Measured: December 2008
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 startSep 2005
- Primary completionJul 2015
- Study completionJul 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 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, DeltaPoint,Inc.
- Responsible party
- Sponsor
- Investigators
- Sunitha Thakur, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582764
- Sponsor's protocol ID
- 05-091
- Status last verified
- Jul 2015
- First submitted
- 21 Dec 2007
- Last updated
- 8 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Dynamic Contrast Enhanced Breast MRI
- ClinicalTrials.gov ID
- NCT00582764
- Acronym / sponsor ID
- 05-091
- Conditions
- Breast Cancer
- Keywords
- Breast Lesion, Lesion, Breast, Cancer, 05-091
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, DeltaPoint,Inc.
- Study start
- Sep 2005
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (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 study is to see if dynamic contrast enhanced (DCE) MRI imaging makes it possible to distinguish benign conditions of the breast from malignant tumors and provide better information than can be obtained with regular MRI. DCE MRI uses a new way of collecting and analyzing the images or pictures which provides doctors extra information not available with standard imaging methods. This includes information about the blood vessels of different breast diseases. Pictures produced this way look just like the regular MRI pictures. The DCE MRI adds another imaging sequence (another scan) to the MRI examination ordered by your physician to evaluate your breast lesion, thus increasing the exam time (extra 10 min). The information gained from doing the new test, the DCE MRI, will not be used in your treatment and will not affect the type of care you receive for your breast lesions.
Detailed description
Our aim is to perform dynamic contrast enhanced (DCE) MRI on 150 patients during their routine breast MRI examination at MSKCC. This will add extra 10 min scanning time to the routine examination. High resolution (submillimeter) parametric maps of pathophysiologic quantities, such as tumor vessel permeability, tumor perfusion, extracellular extravascular volume fraction, will be generated from the DCE MRI data. These results will be correlated with pathology to determine new pharmacokinetic threshold so that the negative predictive value for benign lesions is close to 100%. The improvement in diagnostic specificity may help to reduce unnecessary biopsies in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: perform dynamic contrast enhanced (DCE) MRIAny patient undergoing MRI guided preoperative needle localization or MRI guided biopsy of the breast. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be selected at the time of the MRI interventional procedure by the radiologist who is protocoling the MRI examinations and who is an investigator on this protocol. Any known breast lesion, benign or malignant, will be appropriate for evaluation with DCE MRI. Pathology results will be obtained for each patient as a result of surgery or MRI guided biopsy, allowing correlation between the pathology and DCE MRI data.
Key inclusion criteria (1 listed)
- scheduled for breast MRI interventional procedure for a known breast lesion.
Key exclusion criteria (2 listed)
- 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.
- patients who are unable to cooperate for an MRI, and/or have known reaction to gadolinium contrast agent.
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 |
|---|---|---|
| perform dynamic contrast enhanced (DCE) MRIWith an IV catheter in place, the patient will lie prone on the MRI scanner table with the breasts positioned in the commercial breast coil and then be moved feet first to the center of the MRI scanner. The only difference introduced by the addition of DCE MRI is that before the patient is moved into the scanner for the first time, the IV catheter will be hooked up with a programmable power injector (Medrad, Indianola, PA) which is loaded with Gd contrast and saline. The contrast injection and saline flush will be delivered by the injector while the patient is inside the scanner and the DCE MRI data collection is in process. The Gd contrast dose used for DCE MRI is the same as for clinical MRI: 0.1 mmol/kg. The injection speed of 2 mL/sec is safe and similar to that of manual injection. | Other | 1 |
Primary outcome
To assess whether the new quantitative MRI method can discriminate between malignant and nonmalignant breast lesions among the lesions seen in conventional MRI.
Time frame: December 2008
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 8 Jul 2015.
- Memorial Sloan Kettering Cancer Center websiteLink provided by the sponsor.
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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.
Sunitha Thakur, PhD 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 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 8 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?
To assess whether the new quantitative MRI method can discriminate between malignant and nonmalignant breast lesions among the lesions seen in conventional MRI. (time frame: December 2008). 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 8 Jul 2015.