Back to resultsFrequency Domain Optical Imaging
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MR-guided Near Infrared optical tomography
Sponsored by
About this trial
This is an interventional basic science trial for Breast Cancer
Eligibility Criteria
HEALTHY VOLUNTEERS
Inclusion Criteria:
- 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 Criteria:
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MR-guided NIR
Arm Description
Women with breast abnormalities will undergo an "optical exam" (NIR) in combination with MRI where the NIR light imaging system illuminates the breast from multiple positions covering the area of interest. A total of 60 women will be evaluated: 20 with breast abnormalities receiving gadolinium (Gd) contrast enhancement, 20 with breast abnormalities receiving both Gd-contrast enhancement and indocyanine green (ICG) contrast enhancement, and 20 healthy volunteers not receiving any contrast agents.
Outcomes
Primary Outcome Measures
Compare spatial localization and contrast images of breast abnormalities from MR-guided NIR absorption and fluorescence tomography to NIR absorption and fluorescence tomography alone
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05246735
First Posted
February 16, 2022
Last Updated
May 15, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Dartmouth College
1. Study Identification
Unique Protocol Identification Number
NCT05246735
Brief Title
Frequency Domain Optical Imaging
Official Title
Frequency Domain Optical Imaging of Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2004 (Actual)
Primary Completion Date
June 24, 2022 (Actual)
Study Completion Date
June 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Dartmouth College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
MR-guided NIR absorption and fluorescence imaging of the breast is feasible in the setting of a clinical breast exam
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a clinical study to evaluate MR-guided near infrared absorption and fluorescence imaging
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MR-guided NIR
Arm Type
Other
Arm Description
Women with breast abnormalities will undergo an "optical exam" (NIR) in combination with MRI where the NIR light imaging system illuminates the breast from multiple positions covering the area of interest.
A total of 60 women will be evaluated: 20 with breast abnormalities receiving gadolinium (Gd) contrast enhancement, 20 with breast abnormalities receiving both Gd-contrast enhancement and indocyanine green (ICG) contrast enhancement, and 20 healthy volunteers not receiving any contrast agents.
Intervention Type
Diagnostic Test
Intervention Name(s)
MR-guided Near Infrared optical tomography
Primary Outcome Measure Information:
Title
Compare spatial localization and contrast images of breast abnormalities from MR-guided NIR absorption and fluorescence tomography to NIR absorption and fluorescence tomography alone
Description
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.
Time Frame
During imaging and evaluation by a radiologist or medical technologist, up to 90 minute
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
HEALTHY VOLUNTEERS
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith D Paulsen, PhD
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Frequency Domain Optical Imaging
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