Breast CancerNCT05246735
Frequency Domain Optical Imaging
A study testing MR-guided Near Infrared optical tomography in people with Breast Cancer, run by Dartmouth-Hitchcock Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MR-guided Near Infrared optical tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2004to 24 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Female, ≥ 20 years old.
- Breast size and epithelial integrity adequate to allow NIR imaging exams.
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 15Show fewer
- WOMEN WITH BREAST ABNORMALITIES
- 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.
About this study
Official title: Frequency Domain Optical Imaging of Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- MR-guided Near Infrared optical tomography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided Near Infrared optical tomographyDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| MR-guided NIR | Other | 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. Receives: Diagnostic Test: MR-guided Near Infrared optical tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During imaging and evaluation by a radiologist or medical technologist, up to 90 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Feb 2004
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a clinical study to evaluate MR-guided near infrared absorption and fluorescence imaging
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Principal investigator, Keith D. Paulsen, Dartmouth-Hitchcock Medical Center
- Investigators
- Keith D Paulsen, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246735
- Sponsor's protocol ID
- STUDY00011487
- Status last verified
- May 2023
- First submitted
- 16 Feb 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency Domain Optical Imaging of Breast Cancer
- ClinicalTrials.gov ID
- NCT05246735
- Acronym / sponsor ID
- STUDY00011487
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 1 Feb 2004 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 18 Feb 2022 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a clinical study to evaluate MR-guided near infrared absorption and fluorescence imaging
| Arm | Type | Receives |
|---|---|---|
| MR-guided NIR | Other | Diagnostic Test: MR-guided Near Infrared optical tomographyWomen 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Female, ≥ 20 years old.
Key exclusion criteria (15 listed)
- Absolute or relative contraindication to MRI:
- Pregnancy
- WOMEN WITH BREAST ABNORMALITIES
- Absolute or relative contraindication to MRI:
- Pregnancy
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 |
|---|---|---|
| MR-guided Near Infrared optical tomography | Diagnostic test | MR-guided NIR |
Primary outcome
Compare spatial localization and contrast images of breast abnormalities from MR-guided NIR absorption and fluorescence tomography to NIR absorption and fluorescence tomography alone
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening
Breast Cancer, Ultrasound
RecruitingPhase 3
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Metastatic Breast Cancer
Active, not recruiting
Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening
Breast Cancer Female, BRCA1 Mutation
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. This study is not recruiting at the moment.
Keith D Paulsen, PhD principal investigator
Dartmouth College
Questions about this trial
What is this clinical trial studying?
A study testing MR-guided Near Infrared optical tomography in people with Breast Cancer, run by Dartmouth-Hitchcock Medical Center.
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 9 inclusion and 15 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: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: During imaging and evaluation by a radiologist or medical technologist, up to 90 minute). 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 16 May 2023.