Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:42 AM
Study NCT ID:
NCT07450560
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061766', 'term': 'Proton Therapy'}], 'ancestors': [{'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-07', 'studyFirstSubmitDate': '2026-02-21', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the trajectory and range of the proton beam within the human body', 'timeFrame': '1 day', 'description': 'the three-dimensional dynamic distribution of positron nuclides generated by proton beam irradiation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Proton Therapy', 'fully digital PET', 'in-beam online monitoring'], 'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'The energy transport process of proton beams after entering biological tissue is observed online via proton knife fully digital PET. The dynamic changes of the delivered dose and action range of proton beams in biological tissue are analyzed, the proton dose distribution is reconstructed, and the energy and position of the targeted ablation by proton beams are determined, so as to realize in-beam online PET monitoring for proton therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with solid tumors scheduled to receive proton therapy, with measurable lesions;', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with solid tumors scheduled to receive proton therapy, with measurable lesions;\n2. Signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with a history of radioactive seed implantation;\n2. Patients who cannot understand the purpose of treatment or are unwilling/unable to sign the informed consent form;'}, 'identificationModule': {'nctId': 'NCT07450560', 'briefTitle': 'Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET', 'organization': {'class': 'OTHER', 'fullName': 'Anhui Provincial Cancer Hospital'}, 'officialTitle': 'Full-Digital PET Enables Real-time Monitoring of Proton Range', 'orgStudyIdInfo': {'id': 'CRTOG2602'}}, 'armsInterventionsModule': {'interventions': [{'name': 'proton therapy', 'type': 'RADIATION', 'description': 'proton therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'overallOfficials': [{'name': 'Xiaojing Wang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Anhui Provincial Cancer Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'The energy transport process of proton beams after entering biological tissue is observed online via proton knife fully digital PET. The dynamic changes of the delivered dose and action range of proton beams in biological tissue are analyzed, the proton dose distribution is reconstructed, and the energy and position of the targeted ablation by proton beams are determined, so as to realize in-beam online PET monitoring for proton therapy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shuanghu Yuan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shuanghu Yuan', 'investigatorAffiliation': 'Anhui Provincial Cancer Hospital'}}}}