A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant… (NCT03822312) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant Therapy
United States30 participantsStarted 2019-02-01
Plain-language 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.
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.
Who can participate
Age range18 Years
SexFEMALE
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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…
What they're measuring
1
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.