JOURNAL ONKOLOGIE – STUDIE

A Study of Tumor Imaging With Multispectral Optoacoustic Tomography

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05488483

Studienbeginn:
Juli 2022

Letztes Update:
24.10.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Melanoma

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Memorial Sloan Kettering Cancer Center

Collaborator:
-

Studienleiter

Jan Grimm, MD, PhD
Principal Investigator
Memorial Sloan Kettering Cancer Center

Kontakt

Jan Grimm, MD, PhD
Kontakt:
Phone: 646-888-3095
E-Mail: grimmj@mskcc.org» Kontaktdaten anzeigen

Katja Pinker-Domenig, MD, PhD
Kontakt:
Phone: 646-888-5470
E-Mail: pinkerdk@mskcc.org» Kontaktdaten anzeigen

Studienlocations
(3 von 4)

Helmholtz Institute (Data Analysis Only)
Munich
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Vasilis Ntziachristos, PhD
Phone: +49 (0) 89 3187 3852» Ansprechpartner anzeigen

Memorial Sloan Kettering Bergen (Consent only )
07645 Montvale
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jan Grimm, MD, PhD
Phone: 646-888-3095» Ansprechpartner anzeigen

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
11725 Commack
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jan Grimm, MD, PhD
Phone: 646-888-3095» Ansprechpartner anzeigen

Memorial Sloan - Kettering Cancer Center
10021 New York
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jan Grimm, MD, PhD
Phone: 646-888-3095
E-Mail: grimmj@mskcc.org» Ansprechpartner anzeigen

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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

Geprüfte Regime

Multispectral Optoacoustic Tomography Imaging (MSOT):
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.

Quelle: ClinicalTrials.gov

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