Informations générales (source: ClinicalTrials.gov)
Evaluation of the Clinical Performance of Optimized Angiomammography and Comparison With Standard Angiomammography (OPTIAM)
Observational
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
mai 2017
juin 2019
29 juin 2024
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
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Corinne BALLEYGUIER, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
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.
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.
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.