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Recruiting Observational

Personalization of External Beam Radiation Therapy in Localised Tumours

NCT07047495 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-07
Last updated
2025-07-02

Condition(s) studied

Breast AdenocarcinomaProstate Cancer (Adenocarcinoma)

Investigational drug(s) / intervention(s)

prostate patientbreast patients

prostate patient: patients with prostate cancer treated with RT at IEO

breast patients: patients with breast cancer treated with RT at IEO

Study 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. Histological evaluation and cell culture (and organoid preparation) will be conducted, and samples/organoids will be irradiated with RT for biological validation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria for prostate patients: * 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 ). Exclusion Criteria: * Exclusion criteria for prostate patients: * 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 Exclusion criteria for breast patients: * 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

Primary outcome measure(s)

  • Generation of in-silico tumor model — 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 — 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 — 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07047495 on ClinicalTrials.gov ↗ ← All trials in Italy