Screening Contrast-enhanced Mammography

NCT05390229 | Completed

• 1 other identifier: 2019-4432
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Diagnostic value for suspicious breast lesion

  To determine the ability of diagnostic imaging to identify other breast masses suspicious of cancer.

  Breast cancer screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients referred to the breast clinic at the HSS for a mass suspected of cancer (BIRAD 5) will potentially be considered in the study. These women come either from the Quebec breast cancer screening program, or referred by their attending physician in the investigation of a palpable/symptomatic mass or in an investigation requested for a high-risk patient. These patients will then be referred to us by the attending surgeons as part of the preoperative evaluation of the lesion. Preoperatively, mammography (standard or by tomosynthesis) is considered standard and MRI can also be requested as standard by the surgeon. The patients included will be those for whom an MRI will be prescribed. All patients will receive diagnostic imaging (CESM, MRI and TMN) within 30 days of surgery.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

St-Sacrement Hospital

Québec, Quebec, G1S4L8, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: December 12, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CA (1)