Clinical trial: NCT02891681
Section: Confidentiality
Subsections: How Will You Keep My Information **Confidential?**|Are There Additional Protections For My Health Information?

We will keep your participation in this research study confidential to the extent permitted by law. However, it is possible that other people such as those indicated below may become aware of your participation in this study and may inspect and copy records pertaining to this research. Some of these records could contain information that personally identifies you.  
- Government representatives, (including the Office for Human Research Protections) to complete federal or state responsibilities
- The U.S. Food and Drug Administration - The NIH, funding source of this study
- Your primary care physician if a medical condition that needs urgent attention is discovered
- Public health agencies to complete public health reporting requirements
- Hospital or University representatives, to complete Hospital or University responsibilities - Information about your participation in this study may be documented in your health care records and be available to your health care providers who are not part of the research team.  
- The last four digits of your social security number may be used in hospital or University systems to track billing information for research procedures  
  
- Washington University's Institutional Review Board (a committee that oversees the conduct of research involving human participants) and the Human Research Protection Office. The Institutional Review Board has reviewed and approved this study.  
- The Siteman Cancer Center Clinical Trials Core - The Quality Assurance and Safety Monitoring Committee
The Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital is supported by funding from the National Cancer Institute (NCI). To meet NCI requirements, your protected health information relating to your participation in this study (including your social security number) will be stored in a secure database at the Siteman Cancer Center. This database and also your health care records may be reviewed by Siteman Cancer Center personnel. All information will be securely and confidentially maintained. To help protect your confidentiality, we will store your paper records in a locked office which is in a locked suite, and your electronic data will be stored in a secure server where only members of the research team will have access. If we write a report or article about this study or share the study data set with others, we will do so in such a way that you cannot be directly identified. This consent form or similar documentation that you are participating in a research study will be included in your health care record. Anyone with access to your health care record, including your health insurance company will be able to see that you are participating in a research study. A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by U.S. law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.

Protected Health Information (PHI) is health information that identifies you. PHI is protected by federal law under HIPAA (the Health Insurance Portability and Accountability Act). To take part in this research, you must give the research team permission to use and disclose (share) your PHI for the study as explained in this consent form. The research team will follow state and federal laws and may share your health information with the agencies and people listed under the previous section titled, "How will you keep my information confidential?" Once your health information is shared with someone outside of the research team, it may no longer be protected by HIPAA. The research team will only use and share your information as talked about in this form or as permitted or required by law. When possible, the research team will make sure information cannot be linked to you (de-identified). Once information is de-identified, it may be used and shared for other purposes not discussed in this consent form. If you have questions or concerns about your privacy and the use of your PHI, please contact the University's Privacy Officer at 866-747-4975. Although you will not be allowed to see the study information, you may be given access to your health care records by contacting your health care provider.
Clinical trial: NCT02891681
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study?

If you agree to take part in this study, your involvement will last for up to 6 months, although your active participation will only involve the extra NIR/US scans (each about 30 minutes long) as described above.
Clinical trial: NCT02891681
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of This Study?|Risks Of Nir/Us Scans|Risk Of Breach Of Confidentiality|What If I Am Injured As A Result Of This Study?

You may experience one or more of the risks indicated below from being in this study. In addition to these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this study.

There are no known risks or discomforts associated with the experimental NIR/US scans. The laser used during the NIR/US may cause injury to your eyes. To prevent eye injury, the research team will not turn on the laser until the NIR/US probe is in contact with your skin. Use of ultrasound may heat your breast tissue and could, in extreme situations, result in localized heating and be uncomfortable.

One risk of participating in this study is that confidential information about you may be accidentally disclosed. We will use our best efforts to keep the information about you secure. Please see the section in this consent form titled *"How will you keep my information confidential?"* for more information.

Washington University investigators and staff will try to reduce, control, and treat any complications from this research. If you feel you are injured because of the study, please contact the investigator at (314) 454-7405 and/or the Human Research Protection Office at 1-(800)-438-0445. Decisions about whether payment for medical treatment for injuries relating to your participation in research will be made by Washington University. If you need to seek medical care for a research-related injury, please notify the investigator as soon as possible.
Clinical trial: NCT02891681
Section: Procedures
Subsections: What Will Happen During This Study?

In order to ensure that you are eligible to participate in this study, we will have to confirm your diagnosis and treatment plan. If you are eligible to continue in the study and choose to continue, you will be scheduled for NIR/US imaging as an outpatient in the Department of Radiology at the following time points:  
  
- Baseline (before you begin therapy, but at least 7 days after your initial biopsy) - End of Cycle 1
- End of Cycle 2
- End of Cycle 3
- End of Cycle 5
- At change of treatment drugs (if you are receiving neoadjuvant chemotherapy or hormone therapy)
- Prior to surgery
Please note that End of Cycle 5 only applies to patients whose neoadjuvant chemotherapy drug has changed and there is a need to continue to check for a response.  
For patients receiving endocrine treatment, 'at change of treatment' only applies to patients whose treatment drug has changed and there is a need to continue to check for a response. The NIR/US device is a handheld device that involves using red light delivered by laser diode (similar to the checkout scanner at the supermarket). It takes about 30 minutes to complete each scan. The results of these scans will not be used to make any changes to your treatment. We will also collect data on you, including demographics, imaging reports from routine imaging (such as mammograms, ultrasounds, MRIs, etc.), pathology reports from biopsy and surgery, information on your treatment, and information on your response to treatment. At the request of the investigator, the pathologist may be asked to perform extra staining procedures on existing tissue specimens, but no extra tissue will be taken from you to do these tests.
Clinical trial: NCT02891681
Section: Purpose of Research
Subsections: What Is The Purpose Of This Study?

This is a research study. We invite you to participate in this research study because you have been diagnosed with locally advanced breast cancer and will be receiving routine treatment with neoadjuvant chemotherapy or neoadjuvant hormone therapy This research study is looking at a type of imaging called optical tomography using near infrared diffused light assisted with ultrasound (NIR/US), which uses ultrasound imaging to locate tumors in the breast and optical tomography to look at how the blood supply of the tumor responds to treatment and how well that correlates with the tumor's response to treatment as determined by a pathologist. The purpose of this research study is to evaluate the NIR/US imaging to see if it can predict how your tumor responds to the neoadjuvant therapy. The NIR/US imaging device is considered investigational, which means that it has not been approved by the U.S. Food and Drug Administration (FDA).
Clinical trial: NCT02891681
Section: Voluntary Participation
Subsections: Is Being In This Study Voluntary?

Taking part in this research study is completely voluntary. You may choose not to take part at all. If you decide to be in this study, you may stop participating at any time. Any data that was collected as part of your participation in the study will remain as part of the study records and cannot be removed. If you decide not to be in this study, or if you stop participating at any time, you won't be penalized or lose any benefits for which you otherwise qualify.
Clinical trial: NCT02891681
Section: Withdrawal from Study
Subsections: If You Decide Not To Sign This Form, It Will Not Affect|If You Sign This Form:|What If I Decide To Withdraw From The Study?|Can Someone Else End My Participation In This Study?

- your treatment or the care given by your health provider.  
- your insurance payment or enrollment in any health plans. - any benefits to which you are entitled.  
However, it will not be possible for you to take part in the study.

- You authorize the use of your PHI for this research
- This authorization does not expire.  
- You may later change your mind and not let the research team use or share your information
(you may revoke your authorization).  
- To revoke your authorization, complete the withdrawal letter, found in the Participant section of the Human Research Protection Office website at https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ or you may request that the investigator send you a copy of the letter.  
o **If you revoke your authorization:**
The research team may only use and share information already collected for the study.  
Your information may still be used and shared as necessary to maintain the integrity of the research, for example, to account for a participant's withdrawal from the research study or for safety reasons.  
You will not be allowed to continue to participate in the study.

You may withdraw by telling the study team you are no longer interested in participating in the study or you may send in a withdrawal letter. A sample withdrawal letter can be found at https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ under Withdrawing from a Research Study.

Under certain circumstances, the investigator might decide to end your participation in this research study earlier than planned. This might happen for no reason or because your condition has become worse or funding for the research study has ended.