Breast Screening Clinical Trial
Official title:
Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study
Verified date | April 2023 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | June 21, 2022 |
Est. primary completion date | June 21, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | during MRI, approximately 1 hour | |
Primary | 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. | during MRI, approximately 1 hour | |
Primary | 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. | during MRI, approximately 1 hour |
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