Personalization of External Beam Radiation Therapy in Localised Tumours

NCT ID: NCT07047495

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-31

Study Completion Date

2030-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Adenocarcinoma Prostate Cancer (Adenocarcinoma)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Prostate patients

prostate patients undergoing RT

prostate patient

Intervention Type OTHER

patients with prostate cancer treated with RT at IEO

breast patients

breast patients undergoing RT

breast patients

Intervention Type OTHER

patients with breast cancer treated with RT at IEO

Interventions

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prostate patient

patients with prostate cancer treated with RT at IEO

Intervention Type OTHER

breast patients

patients with breast cancer treated with RT at IEO

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giulia Marvaso

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

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European Institute of Oncology

Milan, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giulia Marvaso, MD

Role: CONTACT

+390294372696

Facility Contacts

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Giulia Marvaso

Role: primary

+390294372696

Other Identifiers

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UID 4631

Identifier Type: -

Identifier Source: org_study_id

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