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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-17

Study Completion Date

2030-09-01

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Breast Cancer Microcalcification Image

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Mammography finding

Describes the mammography finding in patients prior breast surgery

Experimental Intervention

Intervention Type DIAGNOSTIC_TEST

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

Bellona

Describes the finding in the breast tissue samples

Experimental Intervention

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Experimental Intervention

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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control intervention

Eligibility Criteria

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Inclusion Criteria

* \>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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No