Breast CancerMRg-NIRSNCT06400563
MRg-NIRS Imaging System Breast Cancer Trial
A study testing MRg-NIRS in people with Breast Cancer, run by Keith D. Paulsen at 1 site in United States.
Trial summary
This trial is a study of 20 women with breast cancer to evaluate the addition of MR-guided (MRg) near-infrared spectroscopy (NIRS) with and without contrast, as part of a program to improve clinical management of women receiving breast magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 to 83 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRg-NIRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2024to 1 Jul 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 83 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females age ≥ 18 years old
- Participants capable of providing written informed consent
- Women with a recent diagnosis of breast cancer.
- Women who are in pre-surgical planning must have an estimated tumor size of 2.0 cm or less on available imaging.
- Women who are in pre-surgical planning must have had a breast biopsy at least 10 days prior to the MRg-NIRS exam.
Who cannot join
- Participants with 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
- renal failure (FDA's guidance for gadolinium of a creatinine clearance less than 30 mL/1.73 m2 BSA)
- Pregnant women
Show all 9Show fewer
- Breast implants
- Prisoners
- Participants with visually inadequate healing from breast biopsy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shudong Jiang, PhD contact
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Keith D Paulsen, PhD, Keith.D.Paulsen@Dartmouth.edu
Roberta diFlorio-Alexander, MD
About this study
Official title: Evaluation of the Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) Imaging System Platform in Breast Cancer Patients
This trial is a study of 20 women with breast cancer to evaluate the addition of MR-guided (MRg) near-infrared spectroscopy (NIRS) with and without contrast, as part of a program to improve clinical management of women receiving breast magnetic resonance imaging (MRI).
Read the detailed description
This trial is designed to determine if the MRg-NIRS system will contribute significantly to improved clinical management of women receiving breast magnetic resonance imaging (MRI) by achieving diagnostic performance comparable to or better than dynamic contrast-enhanced (DCE) breast MRI alone.
The purpose of this clinical trial is to evaluate the addition of MRg-NIRS with and without contrast in 20 women with breast cancer. The women enrolled in the trial will be those who have a newly diagnosed breast cancer.
- Conditions
- Breast Cancer
- Being tested
- MRg-NIRS
- Keywords
- MRI, MRg-NIRS, Near-infrared Spectroscopy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRg-NIRSDevice
Also called MR-guided NIRS Data Collection
The trial tests the investigator designed and developed Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) imaging system for breast cancer detection. The wearable NIRS imaging system uses 8 flex circuit strips, each with six photo-detectors (PDs) and six source fibers, that are ready to attach to a breast radially by using an adhesive nipple cover and breast tape.
| Study group | Role | What they receive |
|---|---|---|
| MR-guided NIRS | Other | The MRg-NIRS device will be tested to see if it accommodates different breast sizes, covers the breast fully, includes the axilla, is compatible with commercial breast MRI coil and/or biopsy systems, and the signal-to-noise ratio is high enough for MRg-NIRS image reconstruction.
The study team will collect MRI-derived ROI data with T1, T2 and DCE-MRI sequences from 20 women with breast abnormalities and NIRS data concurrently. The study team will also collect diffuse optical signals at 48x48 detector source positions over one side of breast at 6 wavelengths. Receives: Device: MRg-NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical sensitivity of the MRg-NIRS platform
Optical data sensitivity will be measured (The sensitivity of the measurements to a given region identified by MRI, Sr, will be calculated as the sum of the log of the Jacobian times vector r. Here, r is a logical vector that identifies points within the region of interest and J is the Jacobian, the rate of change of measurements to a change in optical properties at a location in the region identified).
Measured: up to one hour on day of MRI
Secondary outcomes (1)
Diagnostic performance of the MRg-NIRS platform
Diagnostic performance will be measured in terms of sensitivity, specificity and area under the receiver-operator characteristic curve (ROC).
Measured: up to one hour on day of MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start25 Nov 2024
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study team will collect MRI-derived region of interest (ROI) data with T1, T2 and DCE-MRI sequences from 20 women with breast abnormalities and NIRS data concurrently. The study team will test whether the breast interface can provide optical measurements with positional data sensitivity \>1%. The study team will conduct two interim analyses of optical sensitivity after completion of 5-10 patient exams to decide whether the breast interface should be modified. The breast interface is a non-significant risk device.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keith D. Paulsen
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Sponsor-investigator, Keith D. Paulsen, Dartmouth-Hitchcock Medical Center
- Investigators
- Keith D. Paulsen, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400563
- Sponsor's protocol ID
- STUDY02001582
- Acronym
- MRg-NIRS
- Status last verified
- Jan 2026
- First submitted
- 11 Apr 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) Imaging System Platform in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06400563
- Acronym / sponsor ID
- MRg-NIRS / STUDY02001582
- Conditions
- Breast Cancer
- Keywords
- MRI, MRg-NIRS, Near-infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Keith D. PaulsenUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2034 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a study of 20 women with breast cancer to evaluate the addition of MR-guided (MRg) near-infrared spectroscopy (NIRS) with and without contrast, as part of a program to improve clinical management of women receiving breast magnetic resonance imaging (MRI).
Detailed description
This trial is designed to determine if the MRg-NIRS system will contribute significantly to improved clinical management of women receiving breast magnetic resonance imaging (MRI) by achieving diagnostic performance comparable to or better than dynamic contrast-enhanced (DCE) breast MRI alone.
The purpose of this clinical trial is to evaluate the addition of MRg-NIRS with and without contrast in 20 women with breast cancer. The women enrolled in the trial will be those who have a newly diagnosed breast cancer.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study team will collect MRI-derived region of interest (ROI) data with T1, T2 and DCE-MRI sequences from 20 women with breast abnormalities and NIRS data concurrently. The study team will test whether the breast interface can provide optical measurements with positional data sensitivity >1%. The study team will conduct two interim analyses of optical sensitivity after completion of 5-10 patient exams to decide whether the breast interface should be modified. The breast interface is a non-significant risk device.
| Arm | Type | Receives |
|---|---|---|
| MR-guided NIRS | Other | Device: MRg-NIRSThe MRg-NIRS device will be tested to see if it accommodates different breast sizes, covers the breast fully, includes the axilla, is compatible with commercial breast MRI coil and/or biopsy systems, and the signal-to-noise ratio is high enough for MRg-NIRS image reconstruction. The study team will collect MRI-derived ROI data with T1, T2 and DCE-MRI sequences from 20 women with breast abnormalities and NIRS data concurrently. The study team will also collect diffuse optical signals at 48x48 detector source positions over one side of breast at 6 wavelengths. |
Who may qualify
- Ages
- 18 to 83 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females age ≥ 18 years old
- Participants capable of providing written informed consent
- Women with a recent diagnosis of breast cancer.
- Women who are in pre-surgical planning must have an estimated tumor size of 2.0 cm or less on available imaging.
- Women who are in pre-surgical planning must have had a breast biopsy at least 10 days prior to the MRg-NIRS exam.
Key exclusion criteria (9 listed)
- Participants with absolute or relative contraindication to MRI:
- Pregnant women
- Breast implants
- Prisoners
- Participants with visually inadequate healing from breast biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRg-NIRSAlso: MR-guided NIRS Data CollectionThe trial tests the investigator designed and developed Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) imaging system for breast cancer detection. The wearable NIRS imaging system uses 8 flex circuit strips, each with six photo-detectors (PDs) and six source fibers, that are ready to attach to a breast radially by using an adhesive nipple cover and breast tape. | Device | MR-guided NIRS |
Primary outcome
Optical sensitivity of the MRg-NIRS platform
Time frame: up to one hour on day of MRI
Optical data sensitivity will be measured (The sensitivity of the measurements to a given region identified by MRI, Sr, will be calculated as the sum of the log of the Jacobian times vector r. Here, r is a logical vector that identifies points within the region of interest and J is the Jacobian, the rate of change of measurements to a change in optical properties at a location in the region identified).
1 secondary outcome
Diagnostic performance of the MRg-NIRS platform
Time frame: up to one hour on day of MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shudong Jiang, PhD contact
Keith D. Paulsen, PhD principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRg-NIRS in people with Breast Cancer, run by Keith D. Paulsen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keith D. Paulsen, PhD (603-646-2695, Keith.D.Paulsen@Dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical sensitivity of the MRg-NIRS platform (time frame: up to one hour on day of MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.