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

NCT06489665 | Recruiting DMC

• 1 other identifier: 2021-00200
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Microcalcification; Image

Keywords

Mammography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Mammography finding

Describes the mammography finding in patients prior breast surgery

Diagnostic Test: Experimental Intervention

Bellona

Describes the finding in the breast tissue samples

Diagnostic Test: Experimental Intervention

Interventions

Experimental Intervention DIAGNOSTIC_TEST

Mammography in the radiology department is commonly performed using General Electrics Medical Systems Senographe Essential device

Also known as: control intervention

Bellona; Mammography finding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \>18 years
• Mastectomy, tumorectomy or biopsy planned
• Informed consent of the patient
• \>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
• \>40 years
• undergoing mammography for screening or diagnostic purpose.
• Informed consent of the patient

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead
• Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland: collaborator
• GratXray AG: collaborator

Study Sites (2)

University Hospital Zurich - Diagnostic Radiology

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

University of Zurich

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Calcinosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Thomas Frau, Prof

  University Hospital Zurich, DIR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Frauenfelder, Prof

CONTACT

+41 44 255 93 83; thomas.frauenfelder@usz.ch

Judith Jehle

CONTACT

0763257051; judith.jehle@usz.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)