Ignite Creation Date:
2024-07-17 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489665
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Brief Title:
Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo a Single-center Prospective Study
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Imaging Quality and Potential Clinical Relevance of Phase Contrast
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Objectives
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
Objectives
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None