A Study of Tumor Imaging With Multispectral Optoacoustic Tomography

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488483
• Other study ID #: 21-374
• Status: Recruiting
• Start date: July 27, 2022
• Est. completion date: July 27, 2025

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Jan Grimm, MD, PhD
• Phone: 646-888-3095
• Email: grimmj[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: July 27, 2025
• Est. primary completion date: July 27, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Melanoma

Intervention

Diagnostic Test:
• Multispectral Optoacoustic Tomography Imaging
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.

Locations

Country	Name	City	State
Germany	Helmholtz Institute (Data Analysis Only)	Munich
United States	Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)	Commack	New York
United States	Memorial Sloan Kettering Bergen (Consent only )	Montvale	New Jersey
United States	Memorial Sloan - Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center