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

ConditionsBreast Cancer Microcalcification Image

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Zurich

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>18 years

Mastectomy, tumorectomy or biopsy planned

Informed consent of the patient

>18 years

Disqualifiers

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.

Trial population

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

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

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

Treatment groups

350 Participants

are divided into 2 treatment groups

Group A: Mammography finding1 intervention

Group B: Bellona1 intervention

Trial outcomes

Primary outcomes

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

Time frame

30 month

Secondary outcomes

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.

Time frame

30 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zurich

Lead sponsor

Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland

Collaborator

GratXray AG