Personalization of External Beam Radiation Therapy in Localised Tumours
Recruiting · NCT07047495 · Observational (researchers observe without assigning treatment) · Lead sponsor: European Institute of Oncology
View the official record on ClinicalTrials.gov →Interventions studied
breast patientsprostate patient
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
2 locations listed.
- European Institute of Oncology - Milan, Italy, Italy
- European Institute of Oncology - Milan, Italy, Italy