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Clinical Trials/NL-OMON39181
NL-OMON39181CompletedNot Applicable

Visualization of breast cancer with the first generation photoacoustic mammoscope - photoacoustic mammography

niversiteit Twente0 sites73 target enrollmentStarted: TBDLast updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
73

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • Photoacoustic part:
  • 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 3-5 (phase 1 and 2) or a BIRADS 1 or 2 (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.;DPS part:
  • 1) all inclusion criteria for photoacoustic imaging;
  • 2) patient who gave informed consent for the photoacoustic imaging study;
  • 3) patient who will have a ultrasound-guided breast biopsy to investigate the lesion, which should be accessible with the VACORA biopsy system.

Exclusion Criteria

  • Photoacoustic part:
  • 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 or radiation therapy on the breast;
  • 5) Patients who are currently undergoing chemotherapy.;DPS part
  • 1) all under 'photoacoustic part'
  • 2) patient who don't gave informed consent for the photoacoustic part
  • 3) patient who use anticoagulantia;
  • 4) patients from which the lesion is inaccessible with the VACORA biopsy needle.

Investigators

Sponsor
niversiteit Twente

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