Optimized Angiomammography and Comparison With Standard Angiomammography (OPTIAM)

Gustave Roussy

Status: Unknown

Conditions: Patients for Whom an Angiomammogram Examination is Requested Whether Its Indication

Treatments: Other: Angiommamography

Study type: Observational

Funder types: Other

Identifiers

NCT03155386

2016/2643 (Other Identifier)

2016-A01566-45

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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)
2. Patient aged 40 to 70 years
3. Informing the patient or his / her legal representative and signing the form of non-opposition.
4. Patient affiliated to a social security system.

Exclusion criteria

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

Trial design

100 participants in 2 patient groups

Standard Angiomammography (SenoBright®)

Treatment:

Other: Angiommamography

Optimized angiomammography

Treatment:

Other: Angiommamography