Personalization of External Beam Radiation Therapy in Localised Tumours

European Institute of Oncology35 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Breast Adenocarcinoma Prostate Cancer (Adenocarcinoma)

Interventions

prostate patientOTHER

patients with prostate cancer treated with RT at IEO

breast patientsOTHER

patients with breast cancer treated with RT at IEO

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

European Institute of Oncology

Milan, Italy, Italy

RECRUITING

Outcomes

Primary Outcomes

Generation of in-silico tumor model

generate an in-silico tumour model able to describe tumour microstructure and its interaction with the radiation beam

Time frame: 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

Time frame: 1 year

Improvement of personalized tumor-models

Improvement of the implemented models, by relying on advanced agnetic Resonance Imaging (MRI) data acquired prospectively

Time frame: 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.

Time frame: 3 years

Central Contacts

Giulia Marvaso, MD

CONTACT

+390294372696 giulia.marvaso@ieo.it

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.