NCT03155386

Optimized Angiomammography and Comparison With Standard Angiomammography

Evaluation of the Clinical Performance of Optimized Angiomammography and Comparison With Standard Angiomammography

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will be proposed consecutively to any patient who angiomammography examination was requested by the clinician in charge of patient. A randomization will be performed between an angiomammography examination Standard (SenoBright®) and an optimized angiomammography examination. A blinded central re-reading of the acquisition technique will be carried out by 3 radiologists (2 seniors and 1 junior) who will evaluate: * The intensity of lesion enhancement * The presence and type of artefacts on the recombined images. * The quality of low-energy images according to recognized criteria for mammography. The gold standard will be histology (biopsies or surgery) or follow-up to 1 year for non-biopsied benign lesions

Conditions

• Patients for Whom an Angiomammogram Examination is Requested Whether Its Indication

Interventions

Type	Name	Description
OTHER	Angiommamography	A blinded central re-reading of the acquisition technique will be carried out by 3 radiologists (2 seniors and 1 junior) who will evaluate: * The intensity of lesion enhancement * The presence and type of artefacts on the recombined images. * The quality of low-energy images according to recognized criteria for mammography. The gold standard will be histology (biopsies or surgery) or follow-up to 1 year for non-biopsied benign lesions

Timeline

• Start date: 2017-05-18
• Primary completion: 2019-10-04
• Completion: 2019-10-04
• First posted: 2017-05-16
• Last updated: 2026-04-01

Locations

1 site across 1 country: France