Breast CancerNCT02033486
Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
A study testing TOBI + DBT in people with Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Screening for breast cancer improves early detection of aggressive cancers and has been shown to reduce breast cancer related mortality. Currently, mammography is the most effective way of detecting early stage, non palpable breast cancers. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TOBI + DBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2021
- 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 30 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any adult female volunteers of any race or ethnic background, between the ages of 30 to 80, either
- scheduled for a clinically indicated diagnostic mammogram or percutaneous biopsy.
- presenting for breast cancer treatment
Who cannot join
- Under 30 years old or over 80 years old
- Is pregnant or thinks she may become pregnant.
- Open wounds on breast
- Breast implants
- Any condition that impairs the ability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stefan Carp
Charlestown, Massachusetts, 02129
Stefan Carp, PhD, 617-643-2230, stefan.carp@mgh.harvard.edu
Mansi Saksena, MBBS, 617-726-3093, MSAKSENA@mgh.harvard.edu
About this study
Screening for breast cancer improves early detection of aggressive cancers and has been shown to reduce breast cancer related mortality. Currently, mammography is the most effective way of detecting early stage, non palpable breast cancers. However, mammography only reveals the breast structure, and cannot say much about the breast physiological state. We propose Tomographic Optical Breast Imaging (TOBI) as an inexpensive, patient friendly technique that is non-invasive and does not use non-ionizing radiation. TOBI uses near infrared light and by measuring how such light passes through the breast, images of blood volume and hemoglobin oxygenation can be obtained. In this study, TOBI is combined with digital breast tomosynthesis (DBT, a form of 3D mammography) and our hypothesis is that the TOBI-DBT combined images can be used to diagnose breast cancer with significantly improved sensitivity and specificity compared to DBT alone.
- Conditions
- Breast Cancer
- Being tested
- TOBI + DBT
- Keywords
- diffuse optical tomography, digital breast tomosynthesis, breast cancer, solid benign lesions, cysts, malignant lesions
- Medical subject headings
- Breast Neoplasms, Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOBI + DBTDevice
Also called Diffuse Optical Tomography + digital breast tomosynthesis
| Study group | Role | What they receive |
|---|---|---|
| TOBI + DBT | Experimental | TOBI + DBT of women presenting for breast imaging. Receives: Device: TOBI + DBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for distinguishing benign vs malignant lesions
We will compare optical-DBT vs DBT in terms of diagnosis specificity within the diagnostic population. We will base our analysis on total hemoglobin contrast which has been shown before by our group to be significantly different between malignant and benign lesions. By setting a threshold total hemoglobin ratio and comparing with the biopsy results, we can obtain a point on the receiver operating characteristic (ROC) for the selected parameter. By sliding the threshold over all possible values, we will render the full ROC curve. The area under the curve (AUC) will be calculated to compare with that of DBT.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (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.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mansi A Saksena, Massachusetts General Hospital
- Investigators
- Stefan A Carp, PhD, Study director, Massachusetts General HospitalMansi Saksena, MBBS, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033486
- Sponsor's protocol ID
- 2013P000488
- Other IDs
- 5R01CA142575, R01CA187595
- Status last verified
- Apr 2019
- First submitted
- 9 Jan 2014
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
- ClinicalTrials.gov ID
- NCT02033486
- Acronym / sponsor ID
- 2013P000488
- Conditions
- Breast Cancer
- Keywords
- diffuse optical tomography, digital breast tomosynthesis, breast cancer, solid benign lesions, cysts, malignant lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2014
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 10 Jan 2014 (estimated)
- 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.
Screening for breast cancer improves early detection of aggressive cancers and has been shown to reduce breast cancer related mortality. Currently, mammography is the most effective way of detecting early stage, non palpable breast cancers. However, mammography only reveals the breast structure, and cannot say much about the breast physiological state. We propose Tomographic Optical Breast Imaging (TOBI) as an inexpensive, patient friendly technique that is non-invasive and does not use non-ionizing radiation. TOBI uses near infrared light and by measuring how such light passes through the breast, images of blood volume and hemoglobin oxygenation can be obtained. In this study, TOBI is combined with digital breast tomosynthesis (DBT, a form of 3D mammography) and our hypothesis is that the TOBI-DBT combined images can be used to diagnose breast cancer with significantly improved sensitivity and specificity compared to DBT alone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOBI + DBT | Experimental | Device: TOBI + DBTTOBI + DBT of women presenting for breast imaging. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any adult female volunteers of any race or ethnic background, between the ages of 30 to 80, either
Key exclusion criteria (5 listed)
- Under 30 years old or over 80 years old
- Is pregnant or thinks she may become pregnant.
- Open wounds on breast
- Breast implants
- Any condition that impairs the ability to give informed consent
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 |
|---|---|---|
| TOBI + DBTAlso: Diffuse Optical Tomography + digital breast tomosynthesis | Device | TOBI + DBT |
Primary outcome
Area under the curve for distinguishing benign vs malignant lesions
Time frame: 5 years
We will compare optical-DBT vs DBT in terms of diagnosis specificity within the diagnostic population. We will base our analysis on total hemoglobin contrast which has been shown before by our group to be significantly different between malignant and benign lesions. By setting a threshold total hemoglobin ratio and comparing with the biopsy results, we can obtain a point on the receiver operating characteristic (ROC) for the selected parameter. By sliding the threshold over all possible values, we will render the full ROC curve. The area under the curve (AUC) will be calculated to compare with that of DBT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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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. This study is not recruiting at the moment.
Stefan A Carp, PhD study director
Massachusetts General Hospital
Mansi Saksena, MBBS principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOBI + DBT in people with Breast Cancer, run by Massachusetts General Hospital 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Carp, PhD (617-643-2230, stefan.carp@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve for distinguishing benign vs malignant lesions (time frame: 5 years). 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 18 Apr 2019.