Personalization of External Beam Radiation Therapy in Localised Tumours

NCT07047495 | Recruiting

• 1 other identifier: UID 4631
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Adenocarcinoma; Prostate Cancer (Adenocarcinoma)

Outcome Measures

Primary Outcomes (4)

• Generation of in-silico tumor model

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

  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

  1 year

• Improvement of personalized tumor-models

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

  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.

  3 years

Study Arms (2)

Prostate patients

prostate patients undergoing RT

Other: prostate patient

breast patients

breast patients undergoing RT

Other: breast patients

Interventions

prostate patient OTHER

patients with prostate cancer treated with RT at IEO

Prostate patients

breast patients OTHER

patients with breast cancer treated with RT at IEO

breast patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include prostate and breast patients undergoing RT.

You may qualify if:

• 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 ).

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy, 20141, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Giulia Marvaso

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulia Marvaso, MD

CONTACT

+390294372696; giulia.marvaso@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 2, 2025

Record last verified: 2024-10

Locations

IT (1)