A Study of Tumor Imaging With Multispectral Optoacoustic Tomography

Study Overview
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Brief Summary
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Participants in this study will have Multispectral Optoacoustic Tomography/MSOT imaging of both breasts immediately before their ultrasound-guided breast biopsy procedure begins. After the MSO imaging is completed, participation in the study will end.

Official Title
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A Feasibility Study of Multispectral Optoacoustic Tomography (MSOT) Imaging in Patients With Tumors

Conditions
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Breast Cancer, Melanoma

Intervention / Treatment
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* Diagnostic Test: Multispectral Optoacoustic Tomography Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is a female or male who is 18 years of age or older. Participant must meet one of the following: Suspicious breast imaging finding detected on either mammography, ultrasound, or MRI that is visible on ultrasound and therefore recommended for ultrasound-guided breast biopsy (BI-RADS 4 suspicious abnormality; BI-RADS 5, highly suggestive for malignancy) No previous treatment for breast cancer Diagnosis of melanoma Exclusion Criteria: Life expectancy < 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast and Melanoma Cohort<br>Participants with a suspicious finding at breast ultrasonography (BI-RADS 4 suspicious abnormality; BI-RADS 5, highly suggestive for malignancy) who are scheduled for ultrasound-guided breast biopsy will undergo MSOT imaging of the suspicious breast tumor detected with ultrasound imaging and any additional lesion present in either breast before undergoing ultrasound-guided breast biopsy as the standard of care. We will evaluate MSOT in 10 patients from the Melanoma Surgical Oncology Clinics (Dr. Ariyan, Co-I) with pathologically confirmed ITM following physical exam and biopsy. We will also evaluate MSOT in five melanoma patients with pathologically confirmed IT metastases scheduled for neoadjuvant immunotherapy prior to surgical resection. | Diagnostic Test: Multispectral Optoacoustic Tomography Imaging<br>* Each participants will undergo MSOT imaging of the suspicious breast tumor detected with ultrasound imaging and any additional lesion present in either breast before undergoing ultrasound-guided breast biopsy as the standard of care. Melanoma participants with pathologically confirmed ITM will undergo MSOT imaging following physical exam and biopsy. Melanoma patients receiving immunotherapy will undergo MSOT imaging prior to and following immunotherapy.<br>* Other names: MSOT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants where tumors were visualized | The primary goal of this study is to evaluate the feasibility of MSOT for breast cancer and melanoma detection. Feasibility is defined as the ability of the method to visualize tumors that have been identified with standard methods (ultrasound, mammography, MRI), and the ability to obtain oxygenation maps of benign and malignant breast and melanoma tumors. MSOT will be considered feasible if it is able to visualize tumors and obtain oxygenation maps in at least 14 patients out of 20 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multispectral Optoacoustic Tomography Imaging, MSOT, Memorial Sloan Kettering Cancer Center, 21-374