Status:
COMPLETED
Frequency Domain Optical Imaging
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Dartmouth College
Conditions:
Breast Cancer
Eligibility:
FEMALE
20+ years
Phase:
NA
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 ...
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 teste...
Eligibility Criteria
Inclusion
- HEALTHY VOLUNTEERS
- Female, ≥20 years old
- Breast size and epithelial integrity adequate to allow NIR imaging exams.
- Ability to provide written informed consent
- No serious associated psychiatric illnesses.
Exclusion
- Absolute or relative contraindication to MRI:
- the presence of an electronic implant, such as a pacemaker
- the presence of a metal implant, such as an aneurysm clip
- claustrophobia
- the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
- Pregnancy
- WOMEN WITH BREAST ABNORMALITIES
- Inclusion:
- Female, ≥ 20 years old.
- Breast size and epithelial integrity adequate to allow NIR imaging exams.
- Ability to provide written informed consent.
- No serious associated psychiatric illnesses.
- A recent screening mammogram that questions the presence of an abnormality, thus requiring further mammographic examination.
- Exclusion:
- Absolute or relative contraindication to MRI:
- the presence of an electronic implant, such as a pacemaker
- the presence of a metal implant, such as an aneurysm clip
- claustrophobia
- the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
- Pregnancy
- A history of allergy to iodides
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05246735
Start Date
February 1 2004
End Date
June 24 2022
Last Update
May 16 2023
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