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A Study of Imaging with Multispectral Optoacoustic Tomography
Trial Status: active
This study evaluates multispectral optoacoustic tomography (MSOT) for imaging of patients with breast and melanoma tumors. MSOT uses pulsed light to create ultrasound waves to identify breast and melanoma tumors and other abnormalities that have been identified with standard imaging methods. Information gathered from this study may help researchers understand how MSOT may be used to for imaging for patients with breast and melanoma tumors.
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 (Breast Imaging Reporting and Data System [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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05488483.
I. To investigate the feasibility of MSOT for breast cancer detection (Breast cohort).
II. Evaluate the clinical feasibility and performance of MSOT for real-time, in vivo detection of ITM in patients with melanoma (Melanoma cohort).
SECONDARY OBJECTIVES:
I. To compare MSOT imaging characteristics of normal breast tissue with suspicious breast tissue as defined by ultrasound (US) (Breast cohort).
II. We will assess the diagnostic performance of MSOT defined by positive predictive value (PPV), negative predictive value (NPV), sensitivity and specificity using histopathology as the standard of reference (Breast cohort).
III. To compare parameters in oxygenation maps of benign and malignant breast tumors from MSOT (Breast cohort).
IV. Explore the feasibility of MSOT as a quantitative biomarker in monitoring response to neoadjuvant immunotherapy in IT metastases prior to surgical resection (Melanoma cohort).
V. Determine how melanin content within an IT metastatic lesion can be quantified in vivo using MSOT and used as a surrogate for the number of viable tumor cells (Melanoma cohort).
VI. Establish how MSOT can detect reductions in melanin content in responding lesions and lack thereof in nonresponding lesions to neoadjuvant immunotherapy (Melanoma cohort).
OUTLINE: This is an observational study.
Breast cancer patients undergo MSOT imaging over 20 minutes followed by standard of care tumor biopsy while on study. Melanoma patients undergo MSOT imaging over 20 minutes after standard of care tumor biopsy.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
