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Recruiting NCT07047495

Personalization of External Beam Radiation Therapy in Localised Tumours

— Observational Breast Adenocarcinoma Prostate Cancer (Adenocarcinoma)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: prostate patient, breast patients.
Who it may be relevant to
Registry conditions: Breast Adenocarcinoma, Prostate Cancer (Adenocarcinoma). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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 outcome measures

  • Generation of in-silico tumor model [Time frame: 1 year]
  • Personalization of the tumour model with patient-specific MR imaging data [Time frame: 1 year]
  • Improvement of personalized tumor-models [Time frame: 3 years]
  • Evaluation of tumor model in describing the in-vivo microstructural and radiobiological characteristics [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • European Institute of Oncology — Milan

Identifiers

NCT: NCT07047495 · UID 4631

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗