Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-31 @ 3:15 AM
Study NCT ID:
NCT07047495
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2025-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalization of External Beam Radiation Therapy in Localised Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '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'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2025-06-24', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Generation of in-silico tumor model', 'timeFrame': '1 year', 'description': 'generate an in-silico tumour model able to describe tumour microstructure and its interaction with the radiation beam'}, {'measure': 'Personalization of the tumour model with patient-specific MR imaging data', 'timeFrame': '1 year', 'description': 'personalize the tumour model implemented in A1 with patient-specific MR imaging data for tumour characterization and treatment outcome prediction, relying on retrospective data'}, {'measure': 'Improvement of personalized tumor-models', 'timeFrame': '3 years', 'description': 'Improvement of the implemented models, by relying on advanced agnetic Resonance Imaging (MRI) data acquired prospectively'}, {'measure': 'Evaluation of tumor model in describing the in-vivo microstructural and radiobiological characteristics', 'timeFrame': '3 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Adenocarcinoma', 'Prostate Cancer (Adenocarcinoma)']}, 'descriptionModule': {'briefSummary': 'The study will include the prospective acquisition of optimized MR imaging data of prostate and breast patients treated with radiotherapy (RT).\n\nWithin 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include prostate and breast patients undergoing RT.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria for prostate patients:\n\n* Unifocal infiltrating ductal breast carcinoma, non-special histotype\n* clinical stage T1-T2,N0\n* No contraindications to MRI, or metal joint prostheses from knee to shoulder included, or femoral stent.\n* Patients aged \\>18 years\n* Good general condition (ECOG 0-2)\n* Expected active treatment (crioablation or surgery or radiotherapy ).\n\nExclusion Criteria:\n\n* Exclusion criteria for prostate patients:\n\n * Nodule involvement and metastasis (cN1 and/or cM1)\n * Concomitant inflammation of the intestine\n * Significant systemic diseases or ongoing oral anticoagulant therapy\n * Non-compliance of dose constraints in the treatment plan\n * Previous invasive cancer, unless the patient has had no disease for at least 3 years\n * Mental disorders that cannot ensure valid informed consent\n\nExclusion criteria for breast patients:\n\n* Histology other than non-special histotype and non-epithelial tumors (sarcoma, lymphoma)\n* Male sex\n* High-risk mutation carrier patients\n* Bilateral breast cancer\n* synchronous distant metastases\n* Neoadjuvant therapy\n* autoimmune connective tissue diseases\n* previous radiotherapy to the chest\n* Mental disorders that cannot ensure valid informed consent\n* No previous thoracic radiotherapy'}, 'identificationModule': {'nctId': 'NCT07047495', 'acronym': 'MINIONS', 'briefTitle': 'Personalization of External Beam Radiation Therapy in Localised Tumours', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'MINIONS - Patient-specific Microstructural and radIobiological Model for persoNalised External Beam radiatION Therapy in Localised tumourS', 'orgStudyIdInfo': {'id': 'UID 4631'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prostate patients', 'description': 'prostate patients undergoing RT', 'interventionNames': ['Other: prostate patient']}, {'label': 'breast patients', 'description': 'breast patients undergoing RT', 'interventionNames': ['Other: breast patients']}], 'interventions': [{'name': 'prostate patient', 'type': 'OTHER', 'description': 'patients with prostate cancer treated with RT at IEO', 'armGroupLabels': ['Prostate patients']}, {'name': 'breast patients', 'type': 'OTHER', 'description': 'patients with breast cancer treated with RT at IEO', 'armGroupLabels': ['breast patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giulia Marvaso', 'role': 'CONTACT', 'email': 'giulia.marvaso@ieo.it', 'phone': '+390294372696'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Giulia Marvaso, MD', 'role': 'CONTACT', 'email': 'giulia.marvaso@ieo.it', 'phone': '+390294372696'}], 'overallOfficials': [{'name': 'Giulia Marvaso', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}