Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-28 @ 8:50 PM
Study NCT ID:
NCT06909604
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2024-12-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Al18F-HER2-BCH PET in Breast Patients Treated With Neoadjuvant Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2024-12-24', 'studyFirstSubmitQcDate': '2025-04-01', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in SUVmax before and after treatment', 'timeFrame': 'Before treatment, 9 weeks after treatment, before surgery', 'description': 'The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'PET/CT', 'Neoadjuvant therapy', 'HER2 expression'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value in breast patients treated with neoadjuvant therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥18 years old; ECOG 0 or 1;\n2. Patients with newly diagnosis HER2 positive or suspicious positive tumors;\n3. Receives neoadjuvant therapy\n4. Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;\n5. Life expectancy \\> 3 months -\n\nExclusion Criteria:\n\n1. Significant hepatic or renal dysfunction;\n2. Is pregnant or ready to pregnant;\n3. Cannot keep their states for half an hour;\n4. Refused to join the clinical research;\n5. Suffering from claustrophobia or other mental disorders;\n6. Any other situation that researchers considered it unsuitable to participate in the trial.'}, 'identificationModule': {'nctId': 'NCT06909604', 'acronym': 'HERfore', 'briefTitle': 'Al18F-HER2-BCH PET in Breast Patients Treated With Neoadjuvant Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Al18F-HER2-BCH PET/CT to Predict Response in Breast Patients Treated With Neoadjuvant Therapy', 'orgStudyIdInfo': {'id': '2019KT114-ZY02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HER2 expression of PET imaging', 'description': 'Evaluate the diagnostic potential of HER2 imaging using 18F-labelled HER2 affibody , evaluate the predictive and prognostic value of HER2 PET imaging in breast cancer patients treated with neoadjuvant therapy', 'interventionNames': ['Radiation: HER2 expression of PET imaging']}], 'interventions': [{'name': 'HER2 expression of PET imaging', 'type': 'RADIATION', 'description': 'Evaluate the diagnostic potential of HER2 imaging using 18F-labelled HER2 affibody , evaluate the predictive and prognostic value of HER2 PET imaging in bladder cancer patients treated with neoadjuvant therapy', 'armGroupLabels': ['HER2 expression of PET imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoyi Guo, PhD', 'role': 'CONTACT', 'email': '15833916752@163.com', 'phone': '01088196495'}, {'name': 'Yannan Yuan', 'role': 'CONTACT', 'email': 'gcp_yuanyn@bjcancer.org', 'phone': '01088197730'}], 'facility': 'Peking University Cancer Hospital & Institute', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiaoyi Guo, PhD', 'role': 'CONTACT', 'email': '15833916752@163.com', 'phone': '010-88196495'}, {'name': 'Yannan Yuan', 'role': 'CONTACT', 'email': 'gcp_yuanyn@bjcancer.org', 'phone': '01088197730'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, {'name': 'North Sichuan Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}