Breast ScreeningNCT03846947
Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study
A study testing MR Fingerprinting in people with Breast Screening, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate potential clinical efficacy of a novel magnetic resonance imaging (MRI) approach, MR fingerprinting, capable of providing quantitative measures of important tissue properties, which could provide important insights into normal breast tissue. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Screening
- What is being tested?
- MR Fingerprinting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2019to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking patients
- Ages 18 to 99 years old
- Scheduled to undergo a screening breast MRI study
- Capable and willing to provide signed informed consent
Who cannot join
- Claustrophobia
- Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
- Known hypersensitivity to contrast agent or to any component of contrast agent refractory to standard medications (antihistamines, steroids)
- Impaired kidney function (serum creatinine level > 1.8 mg/dl or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
- Inability to tolerate MRI (e.g., inability to lie flat for >1 hour)
- Pregnancy or lactating female
- Previous history of mastectomy or lumpectomy
- Breast enhancements (i.e. implants)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
The purpose of this study is to evaluate potential clinical efficacy of a novel magnetic resonance imaging (MRI) approach, MR fingerprinting, capable of providing quantitative measures of important tissue properties, which could provide important insights into normal breast tissue. This new MRI sequence will be added to the screening breast Dynamic Contrast Enhanced (DCE) MRI for high risk normal patients.
Read the detailed description
This is a feasibility study of the use of the additional MR fingerprinting (MRF) scanning sequence with a total of 12 minutes scanning time to our clinical screening breast DCE MRI examination before contrast medium injection and at the end of scan. This additional scanning sequence may provide faster and better quantitative tissue characterization comparing to conventional MR sequences. There is no investigational contrast agent in this study. We propose that the additional MRF sequence may provide faster and more accurate tissue characteristics imaging for clinical evaluation of breast tissue. Patients will be enrolled in with scheduled high risk screening DCE MRI (n=30). The MR imaging will be performed in the clinical 1.5T MR scanners in UNC as normally done for the patients MRI schedule. We only add an additional MRF sequence within the MRI exam just prior to the contrast enhancement scan.
Quantitative measurement of the breast tissue will be performed after the MR exam. The region-of-interest (ROI) of normal breast parenchyma was recorded. The ROI will be saved and encoded to the T1 map, T2 map in MRF, T1 weighted imaging, T2 weighted imaging. A large variety of imaging ROI-based quantitative measures will be calculated among normal glands in bilateral breasts to evaluate different ROI characteristics among different patients and between bilateral breasts in each patient.
- Conditions
- Breast Screening
- Being tested
- MR Fingerprinting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR FingerprintingDevice
The MR fingerprinting technique requires less than 15 minutes total and will be added before and after the standard MRI sequence.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will receive the investigational MR Fingerprinting sequence. Receives: Device: MR Fingerprinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T1 Imaging Sequence
The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the T1 sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of T1 relaxation time, an intrinsic magnetic tissue property that is correlated with a variety of pathological conditions.
Measured: during MRI, approximately 1 hour
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T2 Imaging Sequence
The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the T2 sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of T2 relaxation time, an intrinsic magnetic tissue property that is correlated with a variety of pathological conditions.
Measured: during MRI, approximately 1 hour
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for the Investigational (MRF) Imaging Sequence
The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the investigational (MRF) sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of MRF relaxation time.
Measured: during MRI, approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start18 Feb 2019
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast ScreeningStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cherie Kuzmiak, DO,FACR,FSBI, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846947
- Sponsor's protocol ID
- LCCC1853
- Status last verified
- Apr 2023
- First submitted
- 18 Feb 2019
- Last updated
- 11 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study
- ClinicalTrials.gov ID
- NCT03846947
- Acronym / sponsor ID
- LCCC1853
- Conditions
- Breast Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Posted 11 May 2023
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 evaluate potential clinical efficacy of a novel magnetic resonance imaging (MRI) approach, MR fingerprinting, capable of providing quantitative measures of important tissue properties, which could provide important insights into normal breast tissue. This new MRI sequence will be added to the screening breast Dynamic Contrast Enhanced (DCE) MRI for high risk normal patients.
Detailed description
This is a feasibility study of the use of the additional MR fingerprinting (MRF) scanning sequence with a total of 12 minutes scanning time to our clinical screening breast DCE MRI examination before contrast medium injection and at the end of scan. This additional scanning sequence may provide faster and better quantitative tissue characterization comparing to conventional MR sequences. There is no investigational contrast agent in this study. We propose that the additional MRF sequence may provide faster and more accurate tissue characteristics imaging for clinical evaluation of breast tissue. Patients will be enrolled in with scheduled high risk screening DCE MRI (n=30). The MR imaging will be performed in the clinical 1.5T MR scanners in UNC as normally done for the patients MRI schedule. We only add an additional MRF sequence within the MRI exam just prior to the contrast enhancement scan.
Quantitative measurement of the breast tissue will be performed after the MR exam. The region-of-interest (ROI) of normal breast parenchyma was recorded. The ROI will be saved and encoded to the T1 map, T2 map in MRF, T1 weighted imaging, T2 weighted imaging. A large variety of imaging ROI-based quantitative measures will be calculated among normal glands in bilateral breasts to evaluate different ROI characteristics among different patients and between bilateral breasts in each patient.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: MR FingerprintingAll participants will receive the investigational MR Fingerprinting sequence. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking patients
- Ages 18 to 99 years old
- Scheduled to undergo a screening breast MRI study
- Capable and willing to provide signed informed consent
Key exclusion criteria (8 listed)
- Claustrophobia
- Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
- Known hypersensitivity to contrast agent or to any component of contrast agent refractory to standard medications (antihistamines, steroids)
- Impaired kidney function (serum creatinine level > 1.8 mg/dl or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
- Inability to tolerate MRI (e.g., inability to lie flat for >1 hour)
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 |
|---|---|---|
| MR FingerprintingThe MR fingerprinting technique requires less than 15 minutes total and will be added before and after the standard MRI sequence. | Device | All participants |
Primary outcome
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T1 Imaging Sequence
Time frame: during MRI, approximately 1 hour
The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the T1 sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of T1 relaxation time, an intrinsic magnetic tissue property that is correlated with a variety of pathological conditions.
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T2 Imaging Sequence
Time frame: during MRI, approximately 1 hour
The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the T2 sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of T2 relaxation time, an intrinsic magnetic tissue property that is correlated with a variety of pathological conditions.
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for the Investigational (MRF) Imaging Sequence
Time frame: during MRI, approximately 1 hour
The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the investigational (MRF) sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of MRF relaxation time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Cherie Kuzmiak, DO,FACR,FSBI principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Fingerprinting in people with Breast Screening, run by UNC Lineberger Comprehensive 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 4 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 11 May 2023. 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?
Yes. Results are posted in the registry (first posted 11 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T1 Imaging Sequence (time frame: during MRI, approximately 1 hour). The study lists 3 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 11 May 2023.