Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental Intervention.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Microcalcification, Image. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Imaging Quality and Potential Clinical Relevance of Phase Contrast
Overview
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)
Interventions
- Diagnostic test Experimental Intervention
Mammography in the radiology department is commonly performed using General Electrics Medical Systems Senographe Essential device
Primary outcome measures
- 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. [Time frame: 30 month]
Secondary outcome measures (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. [Time frame: 30 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Switzerland · 2 centers
- University Hospital Zurich - Diagnostic Radiology — Zurich
- University of Zurich — Zurich
Identifiers
NCT: NCT06489665 · 2021-00200