Optimized Angiomammography and Comparison With Standard Angiomammography

NCT03155386 | Completed

• 2 other identifiers: 2016-A01566-452016/2463
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• artefact presence rate

  Compare the artefact presence rate per patient for optimized angiomammography images and images of the Senobright® product.

  up to 12 months

Study Arms (2)

Standard Angiomammography (SenoBright®)

Other: Angiommamography

Optimized angiomammography

Other: Angiommamography

Interventions

Angiommamography OTHER

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

Optimized angiomammography; Standard Angiomammography (SenoBright®)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients for whom an angiomammographic examination is requested regardless of its indication

You may qualify if:

• Patient for whom angiomammography examination is requested regardless of its indication (assessment of extension, clarification of a lesion doubtful after mammography and mammary ultrasound, symptom mammary MRI in a patient with contraindication to MRI)
• Patient aged 40 to 70 years
• Informing the patient or his / her legal representative and signing the form of non-opposition.
• Patient affiliated to a social security system.

You may not qualify if:

• Patient with breast prostheses
• Patient with a genetic mutation (BRCA1, BRCA2, p57)
• Contraindication to injection of iodinated contrast agent
• Pregnant woman, likely to be pregnant or breastfeeding,
• Persons deprived of their liberty or under guardianship,
• Unable to undergo medical follow-up of the trial for reasons geographical, social or psychological.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

Study Design

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

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 16, 2017
• Study Start: May 18, 2017
• Primary Completion: October 4, 2019
• Study Completion: October 4, 2019
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

FR (1)