Screening Contrast-enhanced Mammography

Breast Cancer Clinical Trial

Official title:

Comparison of the Performance of Diagnostic Contrast-enhanced Mammography and Magnetic Resonance Imaging for Suspicious Breast Lesion at Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05390229
• Other study ID #: 2019-4432
• Status: Recruiting
• Start date: December 12, 2018
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: CHU de Quebec-Universite Laval
• Contact: Jean-Charles Hogue
• Phone: 4185254444
• Email: jean-charles.hogue[@]crchudequebec.ulabal.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this study is to compare the diagnostic performance of two diagnostic methods, namely CESM and MRI, in the evaluation of a lesion suspicious of breast cancer in 300 Quebec women referred for the investigation of breast cancer. breast lesion suspected of cancer. All suspicious lesions will be evaluated by these two diagnostic imaging and by TNM. Then, radiologists will respectively interpret diagnostic imaging, without knowing the result of the other imaging in parallel with the study. The sensitivity, specificity, positive predictive value and negative predictive value for his diagnostic imaging will then be determined. Histopathological confirmation by biopsy or surgery will be used as a standard value.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female aged 18 and over
• At least one breast lesion with BIRADS classification 5

Exclusion Criteria:

• Refusal to perform the biopsy or surgery
• Pregnant or possibly pregnant woman
• Usual contraindication to contrast product
• Significant kidney failure
• Allergy to contrast medium
• hyperthyroidism
• Usual contraindications to MRI

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
Canada	St-Sacrement Hospital	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic value for breast cancer	To measure sensitivity, specificity, positive predictive value and negative predictive value for CESM and MRI using histopathological confirmation as a standard value.	Breast cancer screening
Primary	Diagnostic value for suspicious breast lesion	To determine the ability of diagnostic imaging to identify other breast masses suspicious of cancer.	Breast cancer screening