Breast CancerNCT02058758
Quantitative Methods for Supplementing Contrast-Enhanced Magnetic Resonance Imaging of Breast Cancer
An observational study of Breast Cancer, run by University of Minnesota at 1 site in United States.
Trial summary
Contrast-enhanced magnetic resonance imaging (CE-MRI) is now established as the most accurate non-invasive imaging modality for characterizing breast cancer. CE-MRI has a very high sensitivity because the intravenous MR contrast agent highlights regions with increased vascularization and vascular permeability compared… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2014to 1 Sep 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer patients: recruited from the group of patients that have a known cancer and are scheduled to receive a breast MRI at the UMN Center for Clinical Imaging Research (CCIR)
Who may be able to join
- Women scheduled and eligible to receive a contrast-enhanced breast MRI at the UMN Center for Clinical Imaging Research for either standard clinical care, or participation in the ISPY2/ACRIN6698 clinical research study
- Age 18 years or older
- Ability to read and understand English
- Ability to provide written informed consent
Who cannot join
- Subjects who are unlikely to tolerate the longer MRI scanning duration. This may include, history of discomfort during MRI scanning, anxiety, or claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Center for Clinical Imaging Reserach
Minneapolis, Minnesota, 55455
About this study
Contrast-enhanced magnetic resonance imaging (CE-MRI) is now established as the most accurate non-invasive imaging modality for characterizing breast cancer. CE-MRI has a very high sensitivity because the intravenous MR contrast agent highlights regions with increased vascularization and vascular permeability compared to normal breast tissues and benign lesions.
Read the detailed description
Contrast-enhanced magnetic resonance imaging (CE-MRI) is now established as the most accurate non-invasive imaging modality for characterizing breast cancer. CE-MRI has a very high sensitivity because the intravenous MR contrast agent highlights regions with increased vascularization and vascular permeability compared to normal breast tissues and benign lesions. While research continues on improving the specificity of CE-MRI, several other MR techniques that do not require an exogenous contrast agent have been shown to provide valuable information that can improve the characterization of breast cancers. These techniques include magnetic resonance spectroscopy (MRS), diffusion-weighted imaging, and water T2 relaxometry. The long-term goal of this study is to develop these techniques to produce quantitative MR-based biomarkers that can be used to supplement or possibly supplant the information provided by CE-MRI. This project seeks to facilitate the advancement of these advanced, non-contrast techniques. This study uses a piggyback design, in which subjects who are already scheduled to receive a CE-MRI study are invited to receive an additional 10-20 minutes of scanning to help develop these novel methods. This efficient design allows for the refinement and assessment of these new techniques with a minimum of risk and inconvenience to the patient. With these proposed improvements, these techniques may lead to quantitative biomarkers that can guide critical clinical questions in treatment response, diagnosis, staging, and high-risk screening of breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Magnetic Resonance Imaging
- Keywords
- Breast cancer, Magnetic resonance spectroscopy, Diffusion weighted imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
MRI scanning with novel acquisition, reconstruction, and/or analysis methods.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Device: Magnetic Resonance Imaging Receives: Device: Magnetic Resonance Imaging | |
| Breast Cancer Patients | Device: Magnetic Resonance Imaging Receives: Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of choline-containing metabolites
Demonstration of the feasibility of using SLIM-based techniques for acquiring spectoscopic data for quantifying choline and other metabolites in breast cancer.
Measured: Baseline
Secondary outcomes (1)
The apparent diffusion coefficient and T2 relaxation rate of water in the tumor
Develop and optimize methods for performing diffusion weighted imaging and T2 relaxometry in breast cancer.
Measured: Baseline and 6 months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study start1 Mar 2014
- Primary completion1 Jul 2019
- Study completion1 Sep 2019
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Patrick Bolan, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058758
- Sponsor's protocol ID
- 1312M4621
- Other IDs
- R21CA179070
- Status last verified
- Sep 2019
- First submitted
- 31 Jan 2014
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Methods for Supplementing Contrast-Enhanced Magnetic Resonance Imaging of Breast Cancer
- ClinicalTrials.gov ID
- NCT02058758
- Acronym / sponsor ID
- 1312M4621
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Magnetic resonance spectroscopy, Diffusion weighted imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 10 Feb 2014 (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.
Contrast-enhanced magnetic resonance imaging (CE-MRI) is now established as the most accurate non-invasive imaging modality for characterizing breast cancer. CE-MRI has a very high sensitivity because the intravenous MR contrast agent highlights regions with increased vascularization and vascular permeability compared to normal breast tissues and benign lesions.
Detailed description
Contrast-enhanced magnetic resonance imaging (CE-MRI) is now established as the most accurate non-invasive imaging modality for characterizing breast cancer. CE-MRI has a very high sensitivity because the intravenous MR contrast agent highlights regions with increased vascularization and vascular permeability compared to normal breast tissues and benign lesions. While research continues on improving the specificity of CE-MRI, several other MR techniques that do not require an exogenous contrast agent have been shown to provide valuable information that can improve the characterization of breast cancers. These techniques include magnetic resonance spectroscopy (MRS), diffusion-weighted imaging, and water T2 relaxometry. The long-term goal of this study is to develop these techniques to produce quantitative MR-based biomarkers that can be used to supplement or possibly supplant the information provided by CE-MRI. This project seeks to facilitate the advancement of these advanced, non-contrast techniques. This study uses a piggyback design, in which subjects who are already scheduled to receive a CE-MRI study are invited to receive an additional 10-20 minutes of scanning to help develop these novel methods. This efficient design allows for the refinement and assessment of these new techniques with a minimum of risk and inconvenience to the patient. With these proposed improvements, these techniques may lead to quantitative biomarkers that can guide critical clinical questions in treatment response, diagnosis, staging, and high-risk screening of breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: Magnetic Resonance ImagingDevice: Magnetic Resonance Imaging |
| Breast Cancer Patients | – | Device: Magnetic Resonance ImagingDevice: Magnetic Resonance Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients: recruited from the group of patients that have a known cancer and are scheduled to receive a breast MRI at the UMN Center for Clinical Imaging Research (CCIR)
Key inclusion criteria (4 listed)
- Women scheduled and eligible to receive a contrast-enhanced breast MRI at the UMN Center for Clinical Imaging Research for either standard clinical care, or participation in the ISPY2/ACRIN6698 clinical research study
- Age 18 years or older
- Ability to read and understand English
- Ability to provide written informed consent
Key exclusion criteria (1 listed)
- Subjects who are unlikely to tolerate the longer MRI scanning duration. This may include, history of discomfort during MRI scanning, anxiety, or claustrophobia
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 |
|---|---|---|
| Magnetic Resonance ImagingMRI scanning with novel acquisition, reconstruction, and/or analysis methods. | Device | Breast Cancer Patients, Healthy Volunteers |
Primary outcome
Concentration of choline-containing metabolites
Time frame: Baseline
Demonstration of the feasibility of using SLIM-based techniques for acquiring spectoscopic data for quantifying choline and other metabolites in breast cancer.
1 secondary outcome
The apparent diffusion coefficient and T2 relaxation rate of water in the tumor
Time frame: Baseline and 6 months following treatment
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 25 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Patrick Bolan, PhD principal investigator
University of Minnesota
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 University of Minnesota 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 4 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 25 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 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?
Concentration of choline-containing metabolites (time frame: Baseline). 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 25 Sep 2019.