Breast CancerNCT03822312

A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant Therapy

A study testing DBT-TOBI and MRI-TOBI in people with Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This research study is evaluating whether the use of digital breast tomosynthesis and near-infrared tomographic optical breast imaging (DBT-TOBI) scans can predict the response of triple negative or HER2+ breast cancer to neoadjuvant chemotherapy. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: DBT-TOBI and MRI-TOBI
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2019to 31 Dec 2026
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female
Participant will be receiving neoadjuvant chemotherapy at the Massachusetts General Hospital (MGH) Center for Breast Cancer.
Participants must have measurable disease, defined as at least one lesion that can be accurately measured as ≥10 mm in the longest diameter with breast MRI, mammography or ultrasound. See Section 11 for the evaluation of measurable disease.
Patients must have Humane Epidermal Growth Factor Receptor (HER2) positive (regardless of Hormone Receptor (HR) status) or Triple Negative (TN) disease as confirmed by pathology. HER2 positive is defined according to ASCO-CAP guidelines, and patient will be receiving HER2 directed therapy. TN is defined as Estrogen Receptor <=1%, Progesterone Receptor <= 1%, and HER2 negative by American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines. For tumors with discordant or borderline receptor findings, the Principal Investigator will adjudicate the final decision.
Age 18 and above.
Ability to understand and the willingness to sign a written informed consent document

Who cannot join

Patients with open wounds on the breast.
Patients who have undergone breast surgery or breast biopsy 10 days or less prior to the first planned optical imaging scan.
Patients with breast implants.
Patients whose primary lesion is outside the field of view of the optical imaging system.
A history of ipsilateral disease (including invasive breast cancer, ductal carcinoma in situ (DCIS), and benign lesions) or breast surgery.
Patients who are pregnant or trying to become pregnant.

Show all 15Show fewer

Medical or psychiatric conditions which, in the opinion of the investigator, might result in risk to the subject from participation in the study or inability to complete the study.
For patients who agree to participate in the optional MRI study, these following additional exclusion criteria also apply:
Neurostimulators;
Pacemakers;
Implanted metallic material or devices (metal implants or large tattoos in the field of view);
Severe claustrophobia;
Physical characteristics (weight and/or size) that exceed the capabilities of the MRI scanner;
Known allergy or hypersensitivity reactions to gadolinium, versetamide, or any of the inert ingredients in gadolinium-based contrast agents;
Severe renal insufficiency, e.g., estimated glomerular filtration rate < 30 mL/min.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Pilot Study of Digital Breast Tomosynthesis Guided Near-infrared Tomographic Optical Breast Imaging (DBT-TOBI) in Monitoring Response of Breast Cancer to Neoadjuvant Therapy

The study radiologic scan involved in this study is digital breast tomosynthesis (also called 3 Dimensional mammogram) combined with near-infrared tomographic optical breast imaging, or DBT-TOBI.

Read the detailed description

This research study is a Pilot Study, which is the first time investigators are examining this study device for this indication.

The FDA (the U.S. Food and Drug Administration) has not approved DBT-TOBI as a diagnostic scan for this disease.

The DBT-TOBI scan system is designed to deliver low power laser lights through a person's body tissue and collect data about the light that is transmitted through. In this study, the DBT-TOBI will be used to scan the breast. The data that can be collected through the scan is the total hemoglobin concentration and hemoglobin oxygen saturation. Hemoglobin is the protein found in red blood cells that is responsible for carrying oxygen to the various tissues in the body. These two data types are thought to provide insight into the response of the breast cancer to neoadjuvant chemotherapy treatment response. The researchers are looking to find if these scans will help show changes in the hemoglobin levels, thus showing how the cancer is reacting to treatment. The study is focused on 2 types of breast cancer called triple negative breast cancer and Human Epidermal Growth Factor Receptor 2 (HER2).

Conditions: Breast Cancer
Being tested: DBT-TOBI, MRI-TOBI
Keywords: Breast Cancer, Optical imaging, neoadjuvant therapy
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DBT-TOBIDevice
The DBT-TOBI scan system is designed to deliver low power laser lights through a person's body tissue and collect data about the light that is transmitted through
MRI-TOBIDevice
The MRI-TOBI scan system is designed to deliver low power laser lights through a person's body tissue and collect data about the light that is transmitted through. The MRI scan is completed at the same time as the TOBI scan. Participation in this part of the intervention is optional.

Study groups in NCT03822312
Study group	Role	What they receive
DBT-TOBI	Experimental	* Subjects will be imaged using DBT-TOBI at the time points indicated in the Study Calendar (Baseline, before cycle 2, and additional optional time points). * Both breasts will be measured in turn. * Each breast is symmetrically centered on the x-ray detector/optical illuminator and is first compressed according to standard mammography procedures to determine the amount of force needed for each given patient * An optional Magnetic Resonance Imaging TOBI (MRI-TOBI) scan will also be performed. Receives: Device: DBT-TOBI; Device: MRI-TOBI

What is being measured

The primary outcome is the main question the study is designed to answer.

Determining whether DBT-TOBI total hemoglobin concentration measurements before cycle 3 of chemotherapy can predict pathological complete response (pCR) versus non-complete responses in breast cancer.
The primary aim is to evaluate whether early measurements of the total hemoglobin concentration ratio in the primary tumor vs. the surrounding tissue, as estimated by our DBT-TOBI system, can predict neoadjuvant chemotherapy response at the time of surgery. Measurements will be obtained at baseline and just before cycle 3 to determine whether DBT-TOBI is predictive of pathological complete response (pCR) versus non-complete response for Human Epidermal Growth Factor Receptor 2 (HER2) positive and Triple negative breast cancer patients undergoing neoadjuvant chemotherapy.
Measured: 4 to 6 months

Secondary outcomes (8)

Determining the predictive performance of early DBT-TOBI scans before the 3rd cycle of chemotherapy in distinguishing pCR versus non-pCR based on changes in tissue hemoglobin oxygen saturation.
DBT-TOBI measurements of the changes in the ratio of hemoglobin oxygen saturation in the primary tumor versus surrounding normal area between the pre-treatment baseline and immediately before the 3rd cycle of therapy will be used to predict pathological outcome at surgery. The outcome will be quantified using the area under the curve (AUC) after estimating an empirical receiver operating characteristic (ROC) curve for predicting pCR vs non-pCR.
Measured: 4-6 months
Determining whether other optical parameters measured by DBT-TOBI are predictive of the final pathologic response after neoadjuvant therapy.
DBT-TOBI will be used to measure changes in the ratio of tumor to normal hemoglobin oxygen saturation ratio (SO2,T/N) between the baseline and prior to cycle 3 scans, as well as changes in the temporal response of total hemoglobin concentration (HbTT/N) or oxygen saturation (SO2,T/N) under constant mammographic compression.
Measured: 4-6 months
Determining whether DBT-TOBI total hemoglobin concentration measurements before the cycle 2 and after changing chemotherapy can predict pathological complete response (pCR) versus non-complete responses in breast cancer.
DBT-TOBI measurements of the changes in the ratio of total hemoglobin concentration in the primary tumor versus surrounding normal area between the pre-treatment baseline and immediately before the 2nd cycle of therapy and immediately before any change in chemotherapy will be used to predict pathological outcome at surgery.
Measured: 4-6 months
To investigate the ability of DBT-TOBI measurements to predict Residual Cancer Burden (RCB) groups 0 and 1 versus 2 and 3.
The various DBT-TOBI measurements (including the changes in the ratio of total hemoglobin concentration or oxygen saturation in the primary tumor versus surrounding normal area) between the pre-treatment baseline and immediately before the 3rd cycle of therapy and immediately before any change in chemotherapy will be used to predict pathological outcome at surgery. For this objective, the Residual Cancer Burden (RCB) categorization will be used and RCB 0/1 will be compared to RCB 2/3.
Measured: 4-6 months
To investigate whether compression response-based optical property metrics are associated with lesion stiffness as measured by Magnetic Resonance Elastography.
The DBT-TOBI measurements under mammographic compression will be used to compare to the the measurements of tumor stiffness by Magnetic Resonance Imaging elastography. These measurements will be made at baseline and before the 3rd cycle of chemotherapy.
Measured: 4-6 months
To assess the threshold values for detecting pathologic Complete Response (pCR) versus non-PCR and Residual Cancer Burden (RCB) 0/1 versus RCB 2/3, respectively, for changes in optical parameters at standard time points.
For this aim, a Receiver Operator Curve (ROC) will be estimated and used to determine the optimum cut-off value of optical parameters measured by DBT-TOBI from baseline to just prior to the 2nd or 3rd therapy cycle of chemotherapy, and from just before any chemotherapy change to just before the 2nd cycle with the second agent (as applicable), that distinguishes pCR from non-pCR and separately for RCB 0/1 from RCB 2/3.
Measured: 4-6 months
To assess the threshold values for detecting pCR vs. non-PCR and RCB 0/1 versus RCB 2/3, respectively, for changes in MR derived tumor morphology from baseline to just prior the 3rd therapy cycle.
For this aim, a Receiver Operator Curve (ROC) will be estimated and used to determine the optimum cut-off value of MR derived tumor morphology from baseline to just prior to the 2nd or 3rd therapy cycle of chemotherapy, and from just before any chemotherapy change to just before the 2nd cycle with the second agent (as applicable), that distinguishes pCR from non-pCR and separately for RCB 0/1 from RCB 2/3.
Measured: 4-6 months
To compare the predictive abilities between the Receiver Operator Curve (ROC) developed using DBT-TOBI and MR derived tumor morphology measurements to determine which measure more accurately predicts pathologic response.
For this aim, the Receiver Operator Curves (ROC) developed in Outcome 7 (using DBT-TOBI optical parameters) and 8 (using MR derived tumor morphology) will be compared and the difference will be used to determine which measure more accurately identifies patients with pCR vs non-PCR and patients with RCB 0/1 versus RCB 2/3.
Measured: 4-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201931 Dec 2026

First posted30 Jan 2019
Study start1 Feb 2019
Primary completion30 Dec 2026 (estimated)
Study completion31 Dec 2026 (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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03822312
Sponsor's protocol ID: 18-333
Other IDs: 1R01CA187595
Status last verified: Mar 2026
First submitted: 22 Dec 2018
Last updated: 6 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor- Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Digital Breast Tomosynthesis Guided Near-infrared Tomographic Optical Breast Imaging (DBT-TOBI) in Monitoring Response of Breast Cancer to Neoadjuvant Therapy
ClinicalTrials.gov ID: NCT03822312
Acronym / sponsor ID: 18-333
Conditions: Breast Cancer
Keywords: Breast Cancer, Optical imaging, neoadjuvant therapy
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 30 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 1 Feb 2019 (actual)
Primary completion: 30 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 30 Jan 2019 (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.

The study radiologic scan involved in this study is digital breast tomosynthesis (also called 3 Dimensional mammogram) combined with near-infrared tomographic optical breast imaging, or DBT-TOBI.

Detailed description

This research study is a Pilot Study, which is the first time investigators are examining this study device for this indication.

The FDA (the U.S. Food and Drug Administration) has not approved DBT-TOBI as a diagnostic scan for this disease.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DBT-TOBI	Experimental	Device: DBT-TOBI, Device: MRI-TOBI* Subjects will be imaged using DBT-TOBI at the time points indicated in the Study Calendar (Baseline, before cycle 2, and additional optional time points). * Both breasts will be measured in turn. * Each breast is symmetrically centered on the x-ray detector/optical illuminator and is first compressed according to standard mammography procedures to determine the amount of force needed for each given patient * An optional Magnetic Resonance Imaging TOBI (MRI-TOBI) scan will also be performed.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Female
Participant will be receiving neoadjuvant chemotherapy at the Massachusetts General Hospital (MGH) Center for Breast Cancer.
Participants must have measurable disease, defined as at least one lesion that can be accurately measured as ≥10 mm in the longest diameter with breast MRI, mammography or ultrasound. See Section 11 for the evaluation of measurable disease.
Patients must have Humane Epidermal Growth Factor Receptor (HER2) positive (regardless of Hormone Receptor (HR) status) or Triple Negative (TN) disease as confirmed by pathology. HER2 positive is defined according to ASCO-CAP guidelines, and patient will be receiving HER2 directed therapy. TN is defined as Estrogen Receptor <=1%, Progesterone Receptor <= 1%, and HER2 negative by American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines. For tumors with discordant or borderline receptor findings, the Principal Investigator will adjudicate the final decision.
Age 18 and above.

Key exclusion criteria (15 listed)

Patients with open wounds on the breast.
Patients who have undergone breast surgery or breast biopsy 10 days or less prior to the first planned optical imaging scan.
Patients with breast implants.
Patients whose primary lesion is outside the field of view of the optical imaging system.
A history of ipsilateral disease (including invasive breast cancer, ductal carcinoma in situ (DCIS), and benign lesions) or breast surgery.

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
DBT-TOBIThe DBT-TOBI scan system is designed to deliver low power laser lights through a person's body tissue and collect data about the light that is transmitted through	Device	DBT-TOBI
MRI-TOBIThe MRI-TOBI scan system is designed to deliver low power laser lights through a person's body tissue and collect data about the light that is transmitted through. The MRI scan is completed at the same time as the TOBI scan. Participation in this part of the intervention is optional.	Device	DBT-TOBI

Primary outcome

Determining whether DBT-TOBI total hemoglobin concentration measurements before cycle 3 of chemotherapy can predict pathological complete response (pCR) versus non-complete responses in breast cancer.
Time frame: 4 to 6 months
The primary aim is to evaluate whether early measurements of the total hemoglobin concentration ratio in the primary tumor vs. the surrounding tissue, as estimated by our DBT-TOBI system, can predict neoadjuvant chemotherapy response at the time of surgery. Measurements will be obtained at baseline and just before cycle 3 to determine whether DBT-TOBI is predictive of pathological complete response (pCR) versus non-complete response for Human Epidermal Growth Factor Receptor 2 (HER2) positive and Triple negative breast cancer patients undergoing neoadjuvant chemotherapy.

8 secondary outcomes

Determining the predictive performance of early DBT-TOBI scans before the 3rd cycle of chemotherapy in distinguishing pCR versus non-pCR based on changes in tissue hemoglobin oxygen saturation.
Time frame: 4-6 months
Determining whether other optical parameters measured by DBT-TOBI are predictive of the final pathologic response after neoadjuvant therapy.
Time frame: 4-6 months
Determining whether DBT-TOBI total hemoglobin concentration measurements before the cycle 2 and after changing chemotherapy can predict pathological complete response (pCR) versus non-complete responses in breast cancer.
Time frame: 4-6 months
To investigate the ability of DBT-TOBI measurements to predict Residual Cancer Burden (RCB) groups 0 and 1 versus 2 and 3.
Time frame: 4-6 months
To investigate whether compression response-based optical property metrics are associated with lesion stiffness as measured by Magnetic Resonance Elastography.
Time frame: 4-6 months
To assess the threshold values for detecting pathologic Complete Response (pCR) versus non-PCR and Residual Cancer Burden (RCB) 0/1 versus RCB 2/3, respectively, for changes in optical parameters at standard time points.
Time frame: 4-6 months
To assess the threshold values for detecting pCR vs. non-PCR and RCB 0/1 versus RCB 2/3, respectively, for changes in MR derived tumor morphology from baseline to just prior the 3rd therapy cycle.
Time frame: 4-6 months
To compare the predictive abilities between the Receiver Operator Curve (ROC) developed using DBT-TOBI and MR derived tumor morphology measurements to determine which measure more accurately predicts pathologic response.
Time frame: 4-6 months

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 6 Apr 2026.
Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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Not yet recruitingObservational study
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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.

Steven J Isakoff, MD 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 DBT-TOBI and MRI-TOBI 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 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 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?

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?

Determining whether DBT-TOBI total hemoglobin concentration measurements before cycle 3 of chemotherapy can predict pathological complete response (pCR) versus non-complete responses in breast cancer. (time frame: 4 to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03822312.

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 6 Apr 2026.