Clinical Trial - NCT03822312

       

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

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators: National Cancer Institute (NCI)

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Steven J Isakoff, MD, PhD Principal Investigator

ClinicalTrials.gov Identifier: NCT03822312

Protocol Info

Short Description: A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant Therapy
Long Description: 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
MGH Status: Open
Sponsor: DF/HCC
Disease Program: Breast

Next Steps


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Purpose

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.
Condition Title Intervention Phase
Breast Cancer DBT-TOBI MRI-TOBI N/A
Study Type Interventional
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

Primary Outcome Measures

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. [Time Frame: 4 to 6 months] [Designated as safety issue: ]


Secondary Outcome Measures

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. [Time Frame: 4-6 months] [Designated as safety issue: ]

Determining whether other optical parameters measured by DBT-TOBI are predictive of the final pathologic response after neoadjuvant therapy. [Time Frame: 4-6 months] [Designated as safety issue: ]

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. [Time Frame: 4-6 months] [Designated as safety issue: ]

To investigate the ability of DBT-TOBI measurements to predict Residual Cancer Burden (RCB) groups 0 and 1 versus 2 and 3. [Time Frame: 4-6 months] [Designated as safety issue: ]

To investigate whether compression response-based optical property metrics are associated with lesion stiffness as measured by Magnetic Resonance Elastography. [Time Frame: 4-6 months] [Designated as safety issue: ]

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. [Time Frame: 4-6 months] [Designated as safety issue: ]

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. [Time Frame: 4-6 months] [Designated as safety issue: ]

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. [Time Frame: 4-6 months] [Designated as safety issue: ]

Estimated Enrollment: 60
Study Start Date: February 2019
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2023
Arms Assigned Interventions

Experimental:DBT-TOBI

Subjects will be imaged using DBT-TOBI at the time points indicated in the Study Calendar (Baseline, before cycle 2, and additional optional time points). Both breasts will be measured in turn. Each breast is symmetrically centered on the x-ray detector/optical illuminator and is first compressed according to standard mammography procedures to determine the amount of force needed for each given patient An optional Magnetic Resonance Imaging TOBI (MRI-TOBI) scan will also be performed.
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.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: Female

Accepts Healthly Volunteers: No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03822312

Locations

  • United States, Massachusetts
    • Massachusetts General Hospital Cancer Center Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Steven J Isakoff, MD, PhD Principal Investigator
ClinicalTrials.gov Identifier: NCT03822312
Other Study ID Numbers: 1R01CA187595
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

Breast Cancer

Optical imaging

neoadjuvant therapy

Additional relevant MeSH terms:

Breast Neoplasms

Tobramycin

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020