Visualizing breast lesions with the second generation Twente photoacoustic mammoscope (PAM 2)

Visualizing breast lesions with the second generation Twente photoacoustic mammoscope (PAM 2) - photoacoustic mammography 2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47204

Enrollment

130

Registered

2016-11-01

Start date

2016-12-05

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

breast cancer carcinoma of the breast

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Stage 0: - Adult women; - Subjects who are fully competent to give informed consent.;Stage 1: - Adult women who come to the mammapoli with a lesion suspicious for malignancy, which, after clinical investigation and diagnostic imaging is classified as BI-RADS 4 or 5 (stage 1A), or BI-RADS 2 or 3 (stage 1B); - Subjects who are fully competent to give informed consent.

Exclusion criteria

Exclusion criteria: Stage 0: - Subjects who have a cup size of D or larger; - Subjects who have symptoms of breast cancer such as a palpable mass which might be attributed to breast cancer; - Subjects who have had (a) benign breast lesion(s) in the past; - Subjects who have had breast cancer in the past; - Subjects who had a breast biopsy in the 6 months prior to this study; - Subjects with bloody discharge, ulcers or wounds on the breast; - Subjects with a history of surgery (including cosmetic surgery) or radiation therapy on the breast; - Subjects who are currently undergoing chemotherapy.;Deel 1: - Subjects who have a cup size of D or larger; - Subjects who had a breast biopsy in the 6 months prior to this study; - Subjects with bloody discharge, ulcers or wounds on the breast; - Subjects with a history of surgery (including cosmetic surgery) or radiation therapy on the breast; - Subjects who are currently undergoing chemotherapy.

Design outcomes

Primary

Measure	Time frame
The main study parameter is a set of photoacoustic breast images from healthy breasts, breasts containing malignant lesions and breasts containing benign lesions. Photoacoustic images will be qualitatively described and compared to the outcomes of clinical investigation, conventional imaging and pathology. In stage 1A and 1B, we want to find photoacoustic markers indicative for malignant respectively benign lesions. The presence or absence of markers of malignancy will be evaluated in stage 1B. In both stages, photoacoustic appearance of healthy (contralateral) breasts will be investigated.	—

Measure

Time frame

The main study parameter is a set of photoacoustic breast images from healthy breasts, breasts containing malignant lesions and breasts containing benign lesions. Photoacoustic images will be qualitatively described and compared to the outcomes of clinical investigation, conventional imaging and pathology. In stage 1A and 1B, we want to find photoacoustic markers indicative for malignant respectively benign lesions. The presence or absence of markers of malignancy will be evaluated in stage 1B. In both stages, photoacoustic appearance of healthy (contralateral) breasts will be investigated.

—

Secondary

Measure	Time frame
All subjects will be asked to fill out a questionnaire. The questionnaire will contain questions on: - Comfort / burden of the measurement; - Personal information such as age, height, weight, breast size and moment in menstrual cycle at the time of measurement (if applicable).	—

Countries

Netherlands

Outcome results