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NCT Number: NCT07047495

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.

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Key information

Conditions

Breast Adenocarcinoma Adenocarcinoma Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostate Cancer (Adenocarcinoma) Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prostate patient

Other

patients with prostate cancer treated with RT at IEO

breast patients

Other

patients with breast cancer treated with RT at IEO

Primary outcomes

  1. Generation of in-silico tumor model

    Time frame: 1 year

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

  2. Personalization of the tumour model with patient-specific MR imaging data

    Time frame: 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

  3. Improvement of personalized tumor-models

    Time frame: 3 years

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

  4. Evaluation of tumor model in describing the in-vivo microstructural and radiobiological characteristics

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Marvaso, MD

CONTACT

[email protected]

+390294372696

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Acronym: MINIONS

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jul 2, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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