New scan could reveal if chemo is working in just weeks
NCT ID NCT03822312
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests a new type of breast scan called DBT-TOBI, which combines 3D mammography with light-based imaging. Researchers want to see if it can predict how well breast cancer responds to chemotherapy early in treatment. The study involves 30 women with HER2+ or triple-negative breast cancer who are receiving chemotherapy before surgery. If the scan works, it could help doctors know sooner whether to continue or change treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DBT-TOBI scan (device)
- What this could lead to
- If successful, this scan could help doctors know early whether chemotherapy is working for breast cancer patients, allowing them to adjust treatment sooner.
- What could go wrong
- This is a small pilot study with only 30 participants, so results may not apply to everyone. The scan is still experimental and not yet proven to be reliable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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30 people
The number who actually took part.
- Started
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Feb 2019
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215, United States
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