Clinical trial NCT06489665: Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study
Official title: Imaging Quality and Potential Clinical Relevance of Phase Contrast
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Microcalcification
Image
Keywords: Mammography
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland
name: GratXray AG
First posted: 2024-07-08
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who are scheduled to have a mastectomy, tumorectomy or biopsy

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.

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)

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

Primary outcomes:
measure: 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.
timeFrame: 30 month
Secondary outcomes:
measure: Lesion extent will be estimated using both PCM and FFDM. Pathological measurements obtained from the surgical specimen will be used as standard of reference.
timeFrame: 30 month
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich - Diagnostic Radiology
city: Zürich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University Hospital Zurich, DIR
name: Thomas Frau, Prof
role: PRINCIPAL_INVESTIGATOR
References: