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

Plain English Summary

A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant Therapy is a Not Applicable clinical trial sponsored by Massachusetts General Hospital studying Breast Cancer. This study tests a new imaging technology called DBT-TOBI to see if it can predict how well breast cancer responds to chemotherapy before surgery. It is for women with HER2-positive or triple-negative breast cancer who are receiving chemotherapy at Massachusetts General Hospital. Participants will undergo regular DBT-TOBI scans, which involve a special mammogram combined with optical imaging, alongside their standard chemotherapy. Standard treatment monitoring methods like imaging (mammograms, MRI, ultrasound) and pathology reports are the current alternatives. The trial aims to enroll 30 participants.

Official 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

Here is what you need to know about eligibility for this trial. Women aged 18 and older with HER2-positive or triple-negative breast cancer who are starting chemotherapy at MGH. Must have a measurable tumor (at least 10mm) that can be seen on MRI, mammogram, or ultrasound. Cannot have open wounds on the breast, breast implants, or have had breast surgery/biopsy within 10 days of the first scan. Cannot be pregnant or trying to become pregnant, and must not have medical or psychiatric conditions that could interfere with the study. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see if the DBT-TOBI scan can accurately tell if the chemotherapy is shrinking the tumor before surgery, helping doctors understand treatment effectiveness sooner. The specific primary outcome measures are: 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. (4 to 6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to provide an earlier and more precise way to know if chemotherapy is working for aggressive breast cancers, potentially allowing for quicker treatment adjustments. This research targets Breast Cancer, where improved treatment options are needed.

Investor Insight

This pilot study explores a novel imaging technique for a significant cancer type, potentially offering a non-invasive monitoring tool that could improve treatment outcomes and reduce unnecessary ther

Is This Trial Right for Me?

Ask your doctor if DBT-TOBI is suitable for your specific breast cancer type and if it could offer benefits over standard monitoring. Participation involves undergoing the DBT-TOBI scans in addition to your scheduled chemotherapy sessions at Massachusetts General Hospital. The DBT-TOBI scan uses a special mammogram combined with light-based imaging to look inside the breast tissue. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 30 participants

Interventions

• DEVICE: DBT-TOBI — 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
• DEVICE: MRI-TOBI — The MRI-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. The MRI scan is completed at the same time as the TOBI scan. Participation in this part of the intervention is optional.

Primary Outcomes

• 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. (4 to 6 months)

Secondary Outcomes

• 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. (4-6 months)
• Determining whether other optical parameters measured by DBT-TOBI are predictive of the final pathologic response after neoadjuvant therapy. (4-6 months)
• 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. (4-6 months)
• To investigate the ability of DBT-TOBI measurements to predict Residual Cancer Burden (RCB) groups 0 and 1 versus 2 and 3. (4-6 months)
• To investigate whether compression response-based optical property metrics are associated with lesion stiffness as measured by Magnetic Resonance Elastography. (4-6 months)

Full 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.

Trial Locations

• Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Triple-Negative Breast Cancer
• HER2-Positive Breast Cancer
• Neoadjuvant Therapy
• Chemotherapy Response Monitoring
• Oncology Imaging
• Breast Imaging
• Cancer Diagnostics
• Personalized Medicine
• Precision Oncology

More Breast Cancer Trials

View all Breast Cancer clinical trials