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OpenTrials
Completed

NCT Number: NCT03155386

Optimized Angiomammography and Comparison With Standard Angiomammography

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

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Key information

Conditions

Patients for Whom an Angiomammogram Examination is Requested Whether Its Indication

Age range

40 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. artefact presence rate

    Time frame: up to 12 months

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

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

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

Acronym: OPTIAM

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 16, 2017
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.