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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    60
  • sponsor
    Massachusetts General Hospital
Updated on 16 May 2021

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.

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).

Details
Condition Breast Cancer, Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment DBT-TOBI, MRI-TOBI
Clinical Study IdentifierNCT03822312
SponsorMassachusetts General Hospital
Last Modified on16 May 2021

Eligibility

Yes No Not Sure

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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