Breast Cancer
Conditions
Brief summary
This purpose of this clinical study to develop and test technology associated with near infrared (NIR) optical tomography of the breast (the use of light at NIR wavelengths to image the breast) as an adjunct to mammography and breast MRI.
Detailed description
The purpose of this clinical study is to demonstrate the feasibility of NIR absorption and fluorescence imaging of the female breast when the method is guided by breast MRI. The hypotheses to be tested are: 1. MR-guided NIR absorption and fluorescence imaging of the breast is feasible in the setting of a clinical breast exam 2. MR-guided NIR absorption and fluorescence imaging of the breast provides spatial localization and contrast of a breast abnormality that is superior to NIR absorption and fluorescence tomography alone.
Interventions
DIAGNOSTIC_TESTMR-guided Near Infrared optical tomography
Sponsors
Dartmouth College
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
This is a clinical study to evaluate MR-guided near infrared absorption and fluorescence imaging
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
HEALTHY VOLUNTEERS Inclusion Criteria: 1. Female, ≥20 years old 2. Breast size and epithelial integrity adequate to allow NIR imaging exams. 3. Ability to provide written informed consent 4. No serious associated psychiatric illnesses.
Exclusion criteria
1. Absolute or relative contraindication to MRI: 1. the presence of an electronic implant, such as a pacemaker 2. the presence of a metal implant, such as an aneurysm clip 3. claustrophobia 4. the presence of other contraindication(s), as determined by the MRI technologists and radiologists. 2. Pregnancy WOMEN WITH BREAST ABNORMALITIES Inclusion: 1. Female, ≥ 20 years old. 2. Breast size and epithelial integrity adequate to allow NIR imaging exams. 3. Ability to provide written informed consent. 4. No serious associated psychiatric illnesses. 5. A recent screening mammogram that questions the presence of an abnormality, thus requiring further mammographic examination. Exclusion: 1. Absolute or relative contraindication to MRI: 1. the presence of an electronic implant, such as a pacemaker 2. the presence of a metal implant, such as an aneurysm clip 3. claustrophobia 4. the presence of other contraindication(s), as determined by the MRI technologists and radiologists. 2. Pregnancy 3. A history of allergy to iodides 4. A GFR \< 30 ml/min as determined by blood test on the day of NIR/MR imaging, or from lab results within 3 months of NIR/MR imaging.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare spatial localization and contrast images of breast abnormalities from MR-guided NIR absorption and fluorescence tomography to NIR absorption and fluorescence tomography alone | During imaging and evaluation by a radiologist or medical technologist, up to 90 minute | Women will participate in MR-guided NIR exams which include both MR and optical contrast agents. These imaging outcomes will be compared to exams where only the MR contrast agent is used as well as to exams where no contrast agents are administered. |
Outcome results
None listed