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

Imaging Quality and Potential Clinical Relevance of Phase Contrast

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Image; Microcalcification
• Intervention / Treatment: Diagnostic test: Experimental Intervention

Detailed Description

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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 Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Thomas Frauenfelder, Prof; Phone Number: +41 44 255 93 83; Email: thomas.frauenfelder@usz.ch
• Study Contact Backup: Name: Judith Jehle; Phone Number: 0763257051; Email: judith.jehle@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital Zurich - Diagnostic Radiology
    • Contact: Thomas Frauenfelder, PD MD; Phone Number: 0041442551111; Email: thomas.frauenfelder@usz.ch
    • Contact: Thomas Frauenfelder, Prof
  • Zürich, Switzerland
    • Recruiting
    • University of Zurich
    • Contact: Thomas Frauenfelder, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients who are scheduled to have a mastectomy, tumorectomy or biopsy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mammography finding; Describes the mammography finding in patients prior breast surgery	Diagnostic test: Experimental Intervention; Mammography in the radiology department is commonly performed using General Electrics Medical Systems Senographe Essential device; Other Names: control intervention
Bellona; Describes the finding in the breast tissue samples	Diagnostic test: Experimental Intervention; Mammography in the radiology department is commonly performed using General Electrics Medical Systems Senographe Essential device; Other Names: control intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The standard reference will be the histologic specimen after biopsy	30 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion extent will be estimated using both PCM and FFDM. Pathological measurements obtained from the surgical specimen will be used as standard of reference.	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.	30 month

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland; GratXray AG
• Investigators: Principal Investigator: Thomas Frau, Prof, University Hospital Zurich, DIR

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Mammography
• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis
• Other Study ID Numbers: 2021-00200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No