Screening Contrast-enhanced Mammography

NCT ID: NCT05390229

Last Updated: 2025-03-14

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

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-12

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St-Sacrement Hospital

Québec, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jean-Charles Hogue

Role: CONTACT

4185254444 ext. 82424

Facility Contacts

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Jean-Charles Hogue, PhD

Role: primary

4185254444 ext. 82424

Other Identifiers

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2019-4432

Identifier Type: -

Identifier Source: org_study_id

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