Clinical trial · Observational
A Study of Tumor Imaging With Multispectral Optoacoustic Tomography
A Feasibility Study of Multispectral Optoacoustic Tomography (MSOT) Imaging in Patients With Tumors
NCT05488483CI-TRIAL-00103684active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multispectral Optoacoustic Tomography Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast and Melanoma Cohort
- description
- 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.
- interventionNames
- Diagnostic Test: Multispectral Optoacoustic Tomography Imaging
Primary outcomes (1)
- measure
- Number of participants where tumors were visualized
- timeFrame
- 1 year
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.