Patients for Whom an Angiomammogram Examination is Requested Whether Its IndicationOPTIAMNCT03155386
Optimized Angiomammography and Comparison With Standard Angiomammography
An observational study of Patients for Whom an Angiomammogram Examination is Requested Whether Its Indication, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Patients for Whom an Angiomammogram Examination is Requested Whether Its Indication
- What is being tested?
- Angiommamography
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2017to 4 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients for whom an angiomammographic examination is requested regardless of its indication
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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
- Being tested
- Angiommamography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngiommamographyOther
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 group | Role | What they receive |
|---|---|---|
| Standard Angiomammography (SenoBright®) | Not described Receives: Other: Angiommamography | |
| Optimized angiomammography | Not described Receives: Other: Angiommamography |
What is being measured
The primary outcome is the main question the study is designed to answer.
artefact presence rate
Compare the artefact presence rate per patient for optimized angiomammography images and images of the Senobright® product.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start18 May 2017
- Primary completion4 Oct 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients for Whom an Angiomammogram Examination is Requested Whether Its IndicationStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155386
- Sponsor's protocol ID
- 2016-A01566-45
- Other IDs
- 2016/2463
- Acronym
- OPTIAM
- Status last verified
- Mar 2026
- First submitted
- 15 May 2017
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance of Optimized Angiomammography and Comparison With Standard Angiomammography
- ClinicalTrials.gov ID
- NCT03155386
- Acronym / sponsor ID
- OPTIAM / 2016-A01566-45
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 18 May 2017 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Angiomammography (SenoBright®) | – | Other: Angiommamography |
| Optimized angiomammography | – | Other: Angiommamography |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for whom an angiomammographic examination is requested regardless of its indication
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AngiommamographyA 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 | Other | Optimized angiomammography, Standard Angiomammography (SenoBright®) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients for Whom an Angiomammogram Examination is Requested Whether Its Indication, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
artefact presence rate (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.