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Clinical Trials/NCT05488483
NCT05488483
Active, not recruiting
Not Applicable

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

Memorial Sloan Kettering Cancer Center4 sites in 2 countries12 target enrollmentJuly 27, 2022

Overview

Phase
Not Applicable
Intervention
Multispectral Optoacoustic Tomography Imaging
Conditions
Breast Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
12
Locations
4
Primary Endpoint
Number of participants where tumors were visualized
Status
Active, not recruiting
Last Updated
2 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 27, 2022
End Date
July 27, 2026
Last Updated
2 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Breast and Melanoma Cohort

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.

Intervention: Multispectral Optoacoustic Tomography Imaging

Outcomes

Primary Outcomes

Number of participants where tumors were visualized

Time Frame: 1 year

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

Study Sites (4)

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