Breast AdenocarcinomaMINIONSNCT07047495
Personalization of External Beam Radiation Therapy in Localised Tumours
An observational study of Breast Adenocarcinoma and Prostate Cancer (Adenocarcinoma), run by European Institute of Oncology at 1 site in Italy.
Trial summary
The study will include the prospective acquisition of optimized MR imaging data of prostate and breast patients treated with radiotherapy (RT). Within the prospective study, biological specimens from patients undergoing in-room biopsy before RT, will be collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Adenocarcinoma, Prostate Cancer (Adenocarcinoma)
- What is being tested?
- prostate patient and breast patients
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2025to Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include prostate and breast patients undergoing RT.
Who may be able to join
- Unifocal infiltrating ductal breast carcinoma, non-special histotype
- clinical stage T1-T2,N0
- No contraindications to MRI, or metal joint prostheses from knee to shoulder included, or femoral stent.
- Patients aged >18 years
- Good general condition (ECOG 0-2)
- Expected active treatment (crioablation or surgery or radiotherapy ).
Who cannot join
- Nodule involvement and metastasis (cN1 and/or cM1)
- Concomitant inflammation of the intestine
- Significant systemic diseases or ongoing oral anticoagulant therapy
- Non-compliance of dose constraints in the treatment plan
- Previous invasive cancer, unless the patient has had no disease for at least 3 years
- Mental disorders that cannot ensure valid informed consent
Show all 16Show fewer
- Histology other than non-special histotype and non-epithelial tumors (sarcoma, lymphoma)
- Male sex
- High-risk mutation carrier patients
- Bilateral breast cancer
- synchronous distant metastases
- Neoadjuvant therapy
- autoimmune connective tissue diseases
- previous radiotherapy to the chest
- Mental disorders that cannot ensure valid informed consent
- No previous thoracic radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, Italy, 20141
Giulia Marvaso, +390294372696, giulia.marvaso@ieo.it
About this study
Official title: MINIONS - Patient-specific Microstructural and radIobiological Model for persoNalised External Beam radiatION Therapy in Localised tumourS
The study will include the prospective acquisition of optimized MR imaging data of prostate and breast patients treated with radiotherapy (RT).
Within the prospective study, biological specimens from patients undergoing in-room biopsy before RT, will be collected. Histological evaluation and cell culture (and organoid preparation) will be conducted, and samples/organoids will be irradiated with RT for biological validation.
- Being tested
- prostate patient, breast patients
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prostate patientOther
patients with prostate cancer treated with RT at IEO
breast patientsOther
patients with breast cancer treated with RT at IEO
| Study group | Role | What they receive |
|---|---|---|
| Prostate patients | prostate patients undergoing RT Receives: Other: prostate patient | |
| breast patients | breast patients undergoing RT Receives: Other: breast patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of in-silico tumor model
generate an in-silico tumour model able to describe tumour microstructure and its interaction with the radiation beam
Measured: 1 year
Personalization of the tumour model with patient-specific MR imaging data
personalize the tumour model implemented in A1 with patient-specific MR imaging data for tumour characterization and treatment outcome prediction, relying on retrospective data
Measured: 1 year
Improvement of personalized tumor-models
Improvement of the implemented models, by relying on advanced agnetic Resonance Imaging (MRI) data acquired prospectively
Measured: 3 years
Evaluation of tumor model in describing the in-vivo microstructural and radiobiological characteristics
The evaluation of the implemented in-silico tumour model in describing the in-vivo microstructural and radiobiological characteristics, by collecting histopathological features and irradiating primary cell cultures.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Other
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulia Marvaso, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047495
- Sponsor's protocol ID
- UID 4631
- Acronym
- MINIONS
- Status last verified
- Oct 2024
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINIONS - Patient-specific Microstructural and radIobiological Model for persoNalised External Beam radiatION Therapy in Localised tumourS
- ClinicalTrials.gov ID
- NCT07047495
- Acronym / sponsor ID
- MINIONS / UID 4631
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 2 Jul 2025 (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.
The study will include the prospective acquisition of optimized MR imaging data of prostate and breast patients treated with radiotherapy (RT).
Within the prospective study, biological specimens from patients undergoing in-room biopsy before RT, will be collected. Histological evaluation and cell culture (and organoid preparation) will be conducted, and samples/organoids will be irradiated with RT for biological validation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate patients | – | Other: prostate patientprostate patients undergoing RT |
| breast patients | – | Other: breast patientsbreast patients undergoing RT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include prostate and breast patients undergoing RT.
Key inclusion criteria (6 listed)
- Unifocal infiltrating ductal breast carcinoma, non-special histotype
- clinical stage T1-T2,N0
- No contraindications to MRI, or metal joint prostheses from knee to shoulder included, or femoral stent.
- Patients aged >18 years
- Good general condition (ECOG 0-2)
Key exclusion criteria (16 listed)
- Histology other than non-special histotype and non-epithelial tumors (sarcoma, lymphoma)
- Male sex
- High-risk mutation carrier patients
- Bilateral breast cancer
- synchronous distant metastases
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 |
|---|---|---|
| prostate patientpatients with prostate cancer treated with RT at IEO | Other | Prostate patients |
| breast patientspatients with breast cancer treated with RT at IEO | Other | breast patients |
Primary outcome
Generation of in-silico tumor model
Time frame: 1 year
generate an in-silico tumour model able to describe tumour microstructure and its interaction with the radiation beam
Personalization of the tumour model with patient-specific MR imaging data
Time frame: 1 year
personalize the tumour model implemented in A1 with patient-specific MR imaging data for tumour characterization and treatment outcome prediction, relying on retrospective data
Improvement of personalized tumor-models
Time frame: 3 years
Improvement of the implemented models, by relying on advanced agnetic Resonance Imaging (MRI) data acquired prospectively
Evaluation of tumor model in describing the in-vivo microstructural and radiobiological characteristics
Time frame: 3 years
The evaluation of the implemented in-silico tumour model in describing the in-vivo microstructural and radiobiological characteristics, by collecting histopathological features and irradiating primary cell cultures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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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.
Giulia Marvaso principal investigator
European Institute of Oncology
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 Breast Adenocarcinoma and Prostate Cancer (Adenocarcinoma), run by European Institute of Oncology at 1 site in Italy.
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 16 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: looking for participants now, as of the sponsor's last update on 2 Jul 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giulia Marvaso, MD (+390294372696, giulia.marvaso@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generation of in-silico tumor model (time frame: 1 year). The study lists 4 primary outcomes in all. 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 2 Jul 2025.