Status:
ACTIVE_NOT_RECRUITING
A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant Therapy
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 H...
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-T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03822312
Start Date
February 1 2019
End Date
December 31 2026
Last Update
February 27 2025
Active Locations (1)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02215