A Study of Tumor Imaging With Multispectral Optoacoustic Tomography

Active, not recruiting

• Conditions: Breast Cancer; Melanoma
• Interventions: Diagnostic Test: Multispectral Optoacoustic Tomography Imaging

• Registration Number: NCT05488483
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-27
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-07-27
• Study Completion: 2025-07-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast and Melanoma Cohort	Multispectral Optoacoustic Tomography Imaging	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.

Primary Outcome Measures

Name	Time	Method
Number of participants where tumors were visualized	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

Trial Locations

Locations (4)

Memorial Sloan Kettering Bergen (Consent only ); 🇺🇸 Montvale, New Jersey, United States

Helmholtz Institute (Data Analysis Only); 🇩🇪 Munich, Germany

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only); 🇺🇸 Commack, New York, United States

Memorial Sloan - Kettering Cancer Center; 🇺🇸 New York, New York, United States