RecruitingNCT07047495

Personalization of External Beam Radiation Therapy in Localised Tumours

MINIONS - Patient-specific Microstructural and radIobiological Model for persoNalised External Beam radiatION Therapy in Localised tumourS


Sponsor

European Institute of Oncology

Enrollment

35 participants

Start Date

Jul 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria16

  • 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
  • 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

Interventions

OTHERprostate patient

patients with prostate cancer treated with RT at IEO

OTHERbreast patients

patients with breast cancer treated with RT at IEO


Locations(1)

European Institute of Oncology

Milan, Italy, Italy

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NCT07047495


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