NCT07047495 Personalization of External Beam Radiation Therapy in Localised Tumours
| NCT ID | NCT07047495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Breast Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-07 |
| Primary Completion | 2030-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 35 participants in total. It began in 2025-07 with a primary completion date of 2030-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Giulia Marvaso
PRINCIPAL INVESTIGATOR
European Institute of Oncology
Frequently Asked Questions
Who can join the NCT07047495 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07047495 currently recruiting?
Yes, NCT07047495 is actively recruiting participants. Contact the research team at giulia.marvaso@ieo.it for enrollment information.
Where is the NCT07047495 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07047495 clinical trial?
NCT07047495 is sponsored by European Institute of Oncology. The principal investigator is Giulia Marvaso at European Institute of Oncology. The trial plans to enroll 35 participants.