Clinical trial NCT03822312: A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant Therapy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Optical imaging
neoadjuvant therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-01-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 4 to 6 months
Secondary outcomes:
measure: 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.
timeFrame: 4-6 months
measure: Determining whether other optical parameters measured by DBT-TOBI are predictive of the final pathologic response after neoadjuvant therapy.
timeFrame: 4-6 months
measure: 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.
timeFrame: 4-6 months
measure: To investigate the ability of DBT-TOBI measurements to predict Residual Cancer Burden (RCB) groups 0 and 1 versus 2 and 3.
timeFrame: 4-6 months
measure: To investigate whether compression response-based optical property metrics are associated with lesion stiffness as measured by Magnetic Resonance Elastography.
timeFrame: 4-6 months
measure: 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.
timeFrame: 4-6 months
measure: 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.
timeFrame: 4-6 months
measure: 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.
timeFrame: 4-6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven J Isakoff, MD
role: PRINCIPAL_INVESTIGATOR
References: