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Breast imaging using light and sound.

Visualization of breast cancer with the first generation photoacoustic mammoscope.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26509
Enrollment
100
Registered
2011-06-17
Start date
2010-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

No interventions. Measurements: Patients who come to the centre for mammacare with a suspicious breast lesion and who follow the inclusion criteria of the current phase, will be asked for cooperatio

Sponsors

Prof. dr. ir. Wiendelt Steenbergen On behalf of Biomedical Photonic Imaging, University of Twente
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult women, who come to the Centre for Mammacare with a lesion suspicious for malignancy that, after clinical investigation and anamnesis is classified as a BIRADS IV or V (Phase 1,2) or a BIRADS I or II (phase 3) lesion. In addition, the lesion or suspect must have been deemed as being manifestable in a photoacoustic examination; 2. Patients in good general health that allows them to undergo the examination in a prone position for a period of 45 minutes; 3. Patients who are fully competent to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients whose physical condition is expected to be insufficient for mounting the examination bed and staying on this bed for 45 minutes without too much discomfort; 2. Patients who had a breast biopsy in 3 months prior to this study; 3. Patients with bloody discharge, ulcers or wounds on the breast; 4. Patients with a history of surgery (including cosmetic surgery) or radiation therapy on the breast within a period of 5 years prior to the study; 5. Patients with breast implants; 6. Patients who currently undergo chemotherapy.

Design outcomes

Primary

MeasureTime frame
Photoacoustic images will be compared with the outcomes of clinical investigation, conventional imaging and pathology. In the first stage of the study, the photoacoustic images will mainly be used to optimize the measurement and analysis methods. In the second phase of the study, the images of the BIRADS IV and V lesions will qualitatively be described in order to find photoacoustic markers that are indicative for malignancy. In the third stage of the study, which will have a certain overlap with phase 2, also non-cancerous breast will be investigated for the presence or absence of the photoacoustic malignancy markers.

Contacts

Public ContactM. Heijblom

MIRA Institute for Biomedical Technology and Technical Medicine University of Twente P.O. Box 217

m.heijblom@utwente.nl+31 (0)53 4893877

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)