NCT06311695

Brief Summary

The study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM) , considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
263

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Nov 2020

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 24, 2024

Status Verified

March 1, 2024

Enrollment Period

4.3 years

First QC Date

November 21, 2022

Last Update Submit

June 20, 2024

Conditions

Breast Cancer

Keywords

mammographyenhancementContrast Enhanced Mammography

Outcome Measures

Primary Outcomes (1)

  • Evaluation of negative predictive value (NPV) of the CEM

    Assessment of diagnostic accuracy of CEM in dense breasts considering as reference the classification obtained with VABB. Negative predictive value will be expressed as the proportion of patients classified as having no evidence of disease or Ductal Carcinoma In Situ (DCIS) at surgery among all patients with absence of contrast uptake at CEM

    1 month

Secondary Outcomes (3)

  • Evaluation of sensitivity of CEM

    1 month

  • Evaluation of specificity of CEM

    1 month

  • Positive Predictive Value (PPV) of CEM

    1 month

Study Arms (1)

Contrast Enhanced Mammography

EXPERIMENTAL

Patients underwent Contrast Enhanced Mammography

Device: Contrast Enhanced Mammography

Interventions

Contrast Enhanced MammographyDEVICE

Contrast Enhanced Mammography

Contrast Enhanced Mammography

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with breast lesions, who underwent bilateral CEM
  • Histological assessment

You may not qualify if:

  • The subject is known to have risks of adverse effects with iodine contrast agents
  • The subject has breasts too large to be adequately positioned on Full field digital mammography (FFDM) digital receptor without anatomical cut off during an FFDM examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Enrico Cassano, MD

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Cassano, MD

CONTACT

+390257489410enrico.cassano@ieo.it

Luca Nicosia

CONTACT

+390257489410luca.nicosia@ieo.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

March 15, 2024

Study Start

November 16, 2020

Primary Completion

February 28, 2025

Study Completion

December 31, 2025

Last Updated

June 24, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)