Optimized Angiomammography and Comparison With Standard Angiomammography (OPTIAM)

Evaluation of the Clinical Performance of 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

Study Overview

• Status: Unknown
• Conditions: Patients for Whom an Angiomammogram Examination is Requested Whether Its Indication
• Intervention / Treatment: Other: Angiommamography

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Corinne BALLEYGUIER, MD; Phone Number: +33 0142116074; Email: Corinne.balleyguier@gustaveroussy.fr
• Study Contact Backup: Name: Ariane DUNANT, MD; Phone Number: +33 0142115389; Email: ariane.dunant@gustaveroussy.fr

Study Locations

• France
  • Val de Marne
    • Villejuif, Val de Marne, France, 94805
      • Recruiting
      • Gustave Roussy
      • Contact: Corinne BALLEYGUIER, MD; Phone Number: +33 0142116074; Email: Corinne.balleyguier@gustaveroussy.fr
      • Contact: Ariane DUNANT, MD; Phone Number: +33 0142115389; Email: ariane.dunant@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard Angiomammography (SenoBright®)	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
Optimized angiomammography	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
artefact presence rate	Compare the artefact presence rate per patient for optimized angiomammography images and images of the Senobright® product.	up to 12 months

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2016-A01566-45; 2016/2643 (Other Identifier: CSET number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No