Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study

University of Zurich (UZH)

Status: Enrolling

Conditions: Breast Cancer; Image; Microcalcification

Treatments: Diagnostic Test: Experimental Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06489665

2021-00200

Details and patient eligibility

About

Conventional mammography, breast sonography and breast MRI have specific weaknesses. In particular, mammography has a low sensitivity for the detection of mammary carcinoma in patients with a dense breast. Phase contrast mammography could help to overcome some of these limitations. Observational study.

Full description

Category C2 Medicine product without CE label.

Objective(s):

Phase 0: Imaging of mastectomy and breast biopsy samples to validate the image quality and radiation dose. Phase 1: Determination of accurate radiation dose in vivo; dose exposure should remain within the range specified in the investigational brochure. Evaluation of cohort size for phase 2. Phase 2: Assessment of the diagnostic performance of phase contrast mammography compared to conventional digital mammography.

Ouctomes: Sensitivity and specificity of phase contrast mammography compared to conventional digital mammography.

Measurements and procedures:

Phase 0: Phase contrast mammography of the mastectomy, tumorectomy or breast biopsy samples is performed after breast surgery in addition to the standard clinical procedures Phase 1: Phase contrast mammography is performed before the operation in case of known breast carcinoma in addition to the standard clinical procedures Phase 2: Phase contrast mammography is performed directly in the clinical routine. The result is compared with the result of the conventional digital mammography and the ultrasound examination.

Number of Participants with Rationale:

Phase 0: expected to be 30 Phase 1: expected to be 20 Phase 2: expected to be 300 (correct number will be defined according to Phase 1)

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria -Phase 0:

  • >18 years
  • Mastectomy, tumorectomy or biopsy planned
  • Informed consent of the patient

Inclusion criteria -Phase 1:

• >18 years
• BI-RADS 5 (highly suggestive of malignancy at ultrasound or mammography) or 6 (known biopsy proven malignancy);
• Scheduled for mastectomy or breast conserving surgery with radiotherapy.
• Informed consent of the patient

Inclusion criteria - Phase 2:

• >40 years
• undergoing mammography for screening or diagnostic purpose.
• Informed consent of the patient

Exclusion criteria

• Exclusion criteria for all three Phases:

  • Breast implants. The women will be asked, if they have a breast-implant.
  • Inability to understand the study procedure due to cognitive or linguistic deficits.

Exclusion criteria for patients, participating in Phase 1 and Phase 2:

• Pregnancy
• Breast-feeding.
• Re-staging after neoadjuvant chemotherapy. Patients who participated in prior research projects with ionizing radiation in the past 12 months

Trial design

350 participants in 2 patient groups

Mammography finding

Description:

Describes the mammography finding in patients prior breast surgery

Treatment:

Diagnostic Test: Experimental Intervention

Bellona

Description:

Describes the finding in the breast tissue samples

Treatment:

Diagnostic Test: Experimental Intervention