Personalization of External Beam Radiation Therapy in Localised Tumours
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population will include prostate and breast patients undergoing RT.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
prostate patient
Other interventionpatients with prostate cancer treated with RT at IEO
breast patients
Other interventionpatients with breast cancer treated with RT at IEO
Treatment groups
35 Participants
are divided into 2 treatment groupsGroup A: Prostate patients1 intervention
Group B: breast patients1 intervention
Trial outcomes
Primary outcomes
1
Generation of in-silico tumor model
generate an in-silico tumour model able to describe tumour microstructure and its interaction with the radiation beam
Time frame
1 year2
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
Time frame
1 year3
Improvement of personalized tumor-models
Improvement of the implemented models, by relying on advanced agnetic Resonance Imaging (MRI) data acquired prospectively
Time frame
3 years4
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.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov