Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-26 @ 1:14 PM
Study NCT ID:
NCT05412459
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2022-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
99mTc-DARPinG3-based HER2 Expression Molecular Imaging in HER2-positive Breast Cancer During Chemo+Targeted 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor biopsies.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2022-06-02', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SPECT/CT-based 99mTc-DARPinG3 uptake value in primary tumor (standardized uptake value (SUV))', 'timeFrame': '4 hours', 'description': 'SPECT/CT-based 99mTc-DARPinG3 uptake value in primary tumor lesions (SUV) of 99mTc-DARPinG3 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 4 hours after injection and measured in counts and SUV before and after 2 and 4 courses of chemo+targeted therapy'}, {'measure': 'SPECT-based tumor-to-background ratio (conventional units)', 'timeFrame': '4 hours', 'description': 'The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-DARPinG3 uptake coinciding with primary tumor lesions (SUV) will be divided by the value of 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (SUV) before and after 2 and 4 courses of chemo+targeted therapy'}], 'secondaryOutcomes': [{'measure': 'Tumor-to-background ratio 99mTc-DARPinG3 SPECT versus immunohistochemical study', 'timeFrame': '4 hours', 'description': 'Comparison of the 99mTc-DARPinG3 accumulation (SUV or count-to-background ratio) in primary tumour with the results of morphological and immunohistochemical studies (score from 1 to 3) before and after 2 and 4 courses of chemo+targeted therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['99mTc-DARPinG3', 'Breast Cancer', 'HER2 expression', 'chemotherapy and targeted therapy'], 'conditions': ['HER2-positive Breast Cancer', 'Female']}, 'descriptionModule': {'briefSummary': 'An open-label, single center study with 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer in dynamic of chemo+targeted therapy, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-DARPin G3 SPECT and standard histopathology from primary tumor in dynamic of chemo+targeted therapy.', 'detailedDescription': 'none Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer female patients.', 'genderDescription': 'Females', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is \\> 18 years of age;\n2. Diagnosis of primary breast cancer with tumour size ≥ 20 mm and with possible lymph node metastases;\n3. Availability of results from HER2 status previously determined on material from the primary tumor: HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive;\n4. In neoadjuvant all patients should receive standard chemo-targeted therapy according to the DCH+P (docetaxel + carboplatin+ trastuzumab+ pertuzumab) scheme;\n5. Injection of 99mTc-DARPinG3 at the dosage 3000 µg before and after 2 and 4 courses of chemo+targeted therapy in each HER2-positive breast cancer patient;\n6. Biopsies should be performed in all patients HER2-positive breast cancer patients before and after 2 and 4 courses of chemo+targeted therapy with evaluation of HER2 expression;\n7. Hematological, liver and renal function test results within the following limits:\n\n * White blood cell count: \\> 2.0 x 109/L\n * Hemoglobin: \\> 80 g/L\n * Platelets: \\> 50.0 x 109/L\n * ALT, ALP, AST: =\\< 5.0 times Upper Limit of Normal\n * Bilirubin =\\< 2.0 times Upper Limit of Normal\n * Serum creatinine: Within Normal Limits\n8. A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination;\n9. Subject is capable to undergo the diagnostic investigations to be performed in the study;\n10. Informed consent\n\nExclusion Criteria:\n\n1. Second, non-breast malignancy\n2. Active current autoimmune disease or history of autoimmune disease\n3. Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C\n4. Administration of other investigational medicinal product within 30 days of screening\n5. Ongoing toxicity \\> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's"}, 'identificationModule': {'nctId': 'NCT05412459', 'briefTitle': '99mTc-DARPinG3-based HER2 Expression Molecular Imaging in HER2-positive Breast Cancer During Chemo+Targeted Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Tomsk National Research Medical Center of the Russian Academy of Sciences'}, 'officialTitle': 'SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Using 99mTc-DARPinG3 in HER2-positive Breast Cancer Patients in Dynamic of Chemo+Targeted Therapy', 'orgStudyIdInfo': {'id': '99mTc-DARPinG3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The tested injected doses of 99mTc-DARPinG3 3000 μg (SPECT)', 'description': 'Maximum (15) evaluable subjects with HER2-positive status in primary tumour before, after 2 and 4 courses of chemo+targeted therapy have to be enrolled in the study.\n\nSubjects withdrawn from the study for any reason will be replaced.', 'interventionNames': ['Drug: 99mTc-DARPinG3']}], 'interventions': [{'name': '99mTc-DARPinG3', 'type': 'DRUG', 'otherNames': ['Diagnostic injection of 99mTc-DARPinG3.'], 'description': 'Diagnostic test (99mTc-DARPinG3-based SPECT) is used for the assessment of the effect of anticancer therapy.', 'armGroupLabels': ['The tested injected doses of 99mTc-DARPinG3 3000 μg (SPECT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tomsk', 'country': 'Russia', 'facility': 'Tomsk NRMC', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'city': 'Tomsk', 'country': 'Russia', 'facility': 'TomskNRMC', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}], 'overallOfficials': [{'name': 'Olga Bragina, MD, Dsc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tomsk NRMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tomsk National Research Medical Center of the Russian Academy of Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}