Breast CancerRADIOVALNCT05070884
Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer Treatment Planning
An observational study of Breast Cancer, run by Instituto de Investigacion Sanitaria La Fe at 8 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancer
- How many people
- 5,000 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 1 Jun 2023to Dec 2025
- 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 18 to 85 years
- Women only
- Adult, Older adult
Study population: Patients treated with chemotherapy prior to surgery
Who may be able to join
- 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
Who cannot join
- Patient with incomplete or low-quality data (radiological, pathological or clinical)
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Argentina1 site, 1 recruiting
- Not yet recruiting
Alexander Fleming
Buenos Aires
Daniel Cl Mysler
Austria1 site, 1 recruiting
- Not yet recruiting
Medical University of Vienna
Vienna
Pascal Baltzer
Croatia1 site, 1 recruiting
- Not yet recruiting
University of Zagreb School of Medicine
Zagreb
Boris Brkljacic
Egypt1 site, 1 recruiting
- Not yet recruiting
Ain Shams University
Cairo
Abeer Hamed
Poland1 site, 1 recruiting
- Not yet recruiting
Medical University of Gdansk
Gdansk
Maciej Bobowicz, MD, PhD
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario y Politécnico La Fe de Valencia
Valencia, 46026
Gloria Ribas, PHD, gloria_ribas@iislafe.es
Luis Marti-Bonmati, MD, PhD
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinska Institute
Stockholm
Fredrik Strand
Apostolia Tsirikoglou, PhD
Turkey (Türkiye)1 site, 1 recruiting
- Not yet recruiting
Hacettepe University
Ankara
Meltem Gulsun Akpinar
About this study
Official title: Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer
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.
- Conditions
- Breast Cancer
- Being tested
- The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancerOther
Evaluate response to neoadjuvant treatment in advanced breast cancer
| Study group | Role | What they receive |
|---|---|---|
| non respondants of neo treatment | those patients with no response or partial response when administered with Chemotherapy prior to sugery Receives: Other: The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients non-respondents vs respondents in neoadjuvant breast cancer treatment (Estimate tumor aggressiveness)
Proportion of patients who have complete response evaluating the target lesion according to Miller/Payne Grading system [Ogston et al., 2003]: 1A. Evaluation of target Tumor: G5 as pathological complete response, no tumor left; G4:more than 90% loss of tumor cells; G3: between 30-90% reduction in tumor cells; G2: loss of tumor <30%; G1: no reduction. 1B: Evaluating the lymph nodes: A: negative; B: lymph nodes with metastasis and without changes by chemotherapy; C: lymph nodes with metastasis with evidence of partial response, D: lymph nodes with changes attributed to response without residual infiltration. 1C: Using images to evaluated radiological response: Size and diameter in millimeters of the target lesion using RM and TC or PET/CT for extension analysis (lymph nodes and metastasis).
Measured: Baseline and after neoadjuvant treatment (4-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start1 Jun 2023 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Medical University of Gdansk, Medical School University of Zagreb, Medical University of Vienna, Hacettepe University, Instituto Alexander Fleming, Ain Shams University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070884
- Sponsor's protocol ID
- RADIOVAL
- Acronym
- RADIOVAL
- Status last verified
- Sep 2022
- First submitted
- 20 Sep 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/D
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer
- ClinicalTrials.gov ID
- NCT05070884
- Acronym / sponsor ID
- RADIOVAL / RADIOVAL
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Medical University of Gdansk, Medical School University of Zagreb, Medical University of Vienna, Hacettepe University, Instituto Alexander Fleming, Ain Shams University
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Oct 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non respondants of neo treatment | – | Other: The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancerthose patients with no response or partial response when administered with Chemotherapy prior to sugery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients treated with chemotherapy prior to surgery
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Patient with incomplete or low-quality data (radiological, pathological or clinical)
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 |
|---|---|---|
| The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancerEvaluate response to neoadjuvant treatment in advanced breast cancer | Other | non respondants of neo treatment |
Primary outcome
Percentage of patients non-respondents vs respondents in neoadjuvant breast cancer treatment (Estimate tumor aggressiveness)
Time frame: Baseline and after neoadjuvant treatment (4-6 months)
Proportion of patients who have complete response evaluating the target lesion according to Miller/Payne Grading system [Ogston et al., 2003]: 1A. Evaluation of target Tumor: G5 as pathological complete response, no tumor left; G4:more than 90% loss of tumor cells; G3: between 30-90% reduction in tumor cells; G2: loss of tumor <30%; G1: no reduction. 1B: Evaluating the lymph nodes: A: negative; B: lymph nodes with metastasis and without changes by chemotherapy; C: lymph nodes with metastasis with evidence of partial response, D: lymph nodes with changes attributed to response without residual infiltration. 1C: Using images to evaluated radiological response: Size and diameter in millimeters of the target lesion using RM and TC or PET/CT for extension analysis (lymph nodes and metastasis).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No. N/D
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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.
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Instituto de Investigacion Sanitaria La Fe at 8 sites in 8 countries.
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Argentina, Austria, Croatia, Egypt, Poland and 3 more countries. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Penades-Blasco, M.Ec (+34 961245633, ana_penades@iislafe.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients non-respondents vs respondents in neoadjuvant breast cancer treatment (Estimate tumor aggressiveness) (time frame: Baseline and after neoadjuvant treatment (4-6 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 3 Feb 2023.