A Study of Tumor Imaging With Multispectral Optoacoustic Tomography

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	Female

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05488483
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial Sloan Kettering Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jan Grimm, MD, PhD
Principal Investigator Affiliation	Memorial Sloan Kettering Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer, Melanoma
Study Website:	View Trial Website

Arms & Interventions

Arms

: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Montvale, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Bergen (Consent only )

Montvale, New Jersey, 07645

Site Contact

Jan Grimm, MD, PhD

[email protected]

646-888-3095

Commack, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)

Commack, New York, 11725

Site Contact

Jan Grimm, MD, PhD

[email protected]

646-888-3095

Memorial Sloan - Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021

Site Contact

Jan Grimm, MD, PhD

[email protected]

646-888-3095

International Sites

Helmholtz Institute (Data Analysis Only), Munich, Germany

Status

Not yet recruiting

Address

Helmholtz Institute (Data Analysis Only)

Munich, ,

Site Contact

Vasilis Ntziachristos, PhD

[email protected]

+49 (0) 89 3187 3852

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