Clinical trial · Interventional
Frequency Domain Optical Imaging
Frequency Domain Optical Imaging of Breast Cancer
NCT05246735CI-TRIAL-00066474completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-guided Near Infrared optical tomography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MR-guided NIR
- 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.
- interventionNames
- Diagnostic Test: MR-guided Near Infrared optical tomography
Primary outcomes (1)
- measure
- Compare spatial localization and contrast images of breast abnormalities from MR-guided NIR absorption and fluorescence tomography to NIR absorption and fluorescence tomography alone
- timeFrame
- During imaging and evaluation by a radiologist or medical technologist, up to 90 minute
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.