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

Recruiting

• Conditions: Breast Cancer; Microcalcification; Image
• Interventions: Diagnostic Test: Experimental Intervention

• Registration Number: NCT06489665
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed 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)

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-08
• Study Start: 2024-10-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-02
• Last Update Posted: 2025-02-05
• Primary Completion: 2029-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mammowave	Experimental Intervention	-
Bellona	Experimental Intervention	-

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of PCM compared to FFDM represent the primary outcome since the limited sensitivity of mammography, in particular in patients with dense breasts, represents the major limitation of the currently applied FFDM.	30 month	The standard reference will be the histologic specimen after biopsy

Secondary Outcome Measures

Name	Time	Method
Lesion extent will be estimated using both PCM and FFDM. Pathological measurements obtained from the surgical specimen will be used as standard of reference.	30 month	The aim is to evaluate if PCM, due to the expected improved visibility of the lesions, can allow for a better estimation of lesion extent with subsequent benefit on the preoperative planning.

Trial Locations

Locations (2)

University Hospital Zurich - Diagnostic Radiology; 🇨🇭 Zurich, Switzerland

University of Zurich; 🇨🇭 Zürich, Switzerland