MedDataX Logo

Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions

NCT ID: NCT02959398

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Tomosynthesis is an innovative technique developed in digital mammography for obtaining a sectional image of the breast. Mammography has the main disadvantage of being an imaging projection that creates overlays, which eliminates tomosynthesis.

The objective of this study is to evaluate if the BI-RADS classification obtained by tomosynthesis with synthetic mammography is superior to that obtained by conventional mammography in terms of specificity while not inferior in terms of sensitivity.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms Tomosynthesis BRCA1 Protein BRCA2 Protein

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

standard mammography

standard mammography

Group Type ACTIVE_COMPARATOR

Standard mammography

Intervention Type DEVICE

Standard mammography

standard mammography and tomosynthesis

standard mammography and tomosynthesis

Group Type EXPERIMENTAL

Standard mammography and tomosynthesis

Intervention Type DEVICE

Standard mammography and tomosynthesis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard mammography

Standard mammography

Intervention Type DEVICE

Standard mammography and tomosynthesis

Standard mammography and tomosynthesis

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient having clinical or breast imaging abnormalities classified as BiRads 3, 4, 5 (Table 1). (5)
* Patient over 18 years old
* Signed informed consent

Exclusion Criteria

* Patients at high risk of breast cancer, mutations BRCA 1 (BReast CAncer gene 1) or BRCA 2 (BReast CAncer gene 2) carriers, Li Fraumeni, or history of thoracic radiation will be excluded because of their greater sensitivity to ionizing radiation.
* Patient unable to give informed consent for physical, mental, or legal reasons.
* Patient not affiliated with French Social Security Insurance.
* Patient under treatment for breast cancer.
* When mammography is not recommended according to good practice by the French Health Authority (HAS).
* Pregnant patient.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

hopital Saint-Louis

Paris, , France

Site Status RECRUITING

Hopital Tenon

Paris, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

cedric De Bazelaire, MD PHD

Role: CONTACT

Phone: 142499133

Email: [email protected]

Matthieu Resche-Rigon, MD PHD

Role: CONTACT

Phone: 142499742

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

matthieu resche-rigon

Role: primary

Isabelle THOMASSIN- NAGGARA, Pr

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P120121

Identifier Type: -

Identifier Source: org_study_id