Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer Treatment Planning

NCT ID: NCT05070884

Last Updated: 2023-02-03

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

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-12-31

Brief Summary

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

RadioVal will develop and implement interoperable solutions for clinical deployment of the radiomics tools, including information, training, and communication packages for clinicians and patients, as well as standard operating procedures for the integration of radiomics in clinical oncology. With this study, we will clinically validate these solutions, by looking at their reliability for precise breast cancer diagnosis, treatment recommendation and prognosis estimate, treatment response, evaluation of residual disease and outcome prediction.

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 Cancer

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

non respondants of neo treatment

those patients with no response or partial response when administered with Chemotherapy prior to sugery

The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancer

Intervention Type OTHER

Evaluate response to neoadjuvant treatment in advanced breast cancer

Interventions

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

The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancer

Evaluate response to neoadjuvant treatment in advanced breast cancer

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Females ≥ 18 years up to 85 years old
* Individuals referred to hospitals for diagnosis of breast cancer
* Availability of radiological images: 2D mammography or 2D synthetic digital tomosynthesis, ultrasound, or magnetic resonance
* Availability of pathological report (surgical specimen)
* Availability of (Neoadjuvant) treatment allocation (scheme, duration, benefit)
* Availability of treatment response

Exclusion Criteria

* Patient with incomplete or low-quality data (radiological, pathological or clinical)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

Karolinska Institutet

OTHER

Sponsor Role collaborator

Medical University of Gdansk

OTHER

Sponsor Role collaborator

Medical School University of Zagreb

UNKNOWN

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role collaborator

Hacettepe University Hospital

UNKNOWN

Sponsor Role collaborator

Alexander Fleming Institute

UNKNOWN

Sponsor Role collaborator

Ain Shams University

OTHER

Sponsor Role collaborator

Instituto de Investigacion Sanitaria La Fe

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.

Alexander Fleming

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Medical University of Vienna

Vienna, , Austria

Site Status NOT_YET_RECRUITING

University of Zagreb School of Medicine

Zagreb, , Croatia

Site Status NOT_YET_RECRUITING

Ain Shams University

Cairo, , Egypt

Site Status NOT_YET_RECRUITING

Medical University of Gdansk

Gdansk, , Poland

Site Status NOT_YET_RECRUITING

Hospital Universitario y Politécnico La Fe de Valencia

Valencia, , Spain

Site Status RECRUITING

Karolinska Institute

Stockholm, , Sweden

Site Status NOT_YET_RECRUITING

Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Countries

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

Argentina Austria Croatia Egypt Poland Spain Sweden Turkey (Türkiye)

Central Contacts

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

Ana Penades-Blasco, M.Ec

Role: CONTACT

+34 961245633

Facility Contacts

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

Gloria Ribas, PHD

Role: primary

Other Identifiers

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

RADIOVAL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.