Recruiting

Personalization of 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.

ClinicalTrials.gov IDNCT07047495

PhaseNot Applicable

Enrollment35

SponsorEuropean Institute of Oncology

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Adenocarcinoma, Prostate Cancer (Adenocarcinoma)

About this study

Interventions

Other: prostate patient — patients with prostate cancer treated with RT at IEO
Other: breast patients — patients with breast cancer treated with RT at IEO

Primary outcomes

Generation of in-silico tumor model (1 year)
Personalization of the tumour model with patient-specific MR imaging data (1 year)
Improvement of personalized tumor-models (3 years)
Evaluation of tumor model in describing the in-vivo microstructural and radiobiological characteristics (3 years)

Eligibility information

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

Study locations

European Institute of Oncology, Milan, Italy 20141 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.