Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 3:03 PM
Study NCT ID:
NCT07107633
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Clinical Study to Evaluate the Efficacy and Safety of Technetium [99mtc]-H7ND Injection in the Diagnosis of Peritoneal Metastasis of Gastrointestinal Malignant Tumor.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013667', 'term': 'Technetium'}], 'ancestors': [{'id': 'D004603', 'term': 'Elements, Radioactive'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D011868', 'term': 'Radioisotopes'}, {'id': 'D007554', 'term': 'Isotopes'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the effectiveness of technetium [99mTc]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor', 'timeFrame': '1-7 days from time of injection', 'description': 'To evaluate whether the sensitivity of 99mTc-H7ND SPECT/CT in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor is better than that of enhanced CT by SOT.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor', 'Peritoneal Metastasis']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the effectiveness of technetium \\[99mTc\\]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor. Objective: To evaluate the safety of technetium \\[99mTc\\]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor. Objective: To explore the diagnostic threshold of technetium \\[99mTc\\]-H7ND injection for peritoneal metastasis of gastrointestinal malignant tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nOnly those who meet all the following requirements are eligible to join the group:\n\n1. Adults over 18 years of age (based on the time when the informed consent form was signed) can be male or female;\n2. Subjects with gastrointestinal malignant tumor confirmed by histology/cytology;\n3. Subjects to be surgically removed or explored;\n4. The estimated survival time is ≥12 weeks;\n5. Subjects of childbearing age agreed to adopt effective contraceptive measures during the study period;\n6. Subjects fully understand the purpose, nature, methods and possible adverse reactions of the experiment, voluntarily participate in and sign a written informed consent, and are willing to follow the requirements of the protocol to complete the study.riteria:\n\nThose who meet one of the following items are not allowed to join the group:\n\n1. According to the researcher's judgment, during the screening period, from the imaging examination to the comprehensive real diagnosis information result, the patients were treated with anti-digestive tract tumor;\n2. symptomatic brain metastases who need treatment;\n3. Have serious cardiovascular and cerebrovascular diseases;\n4. There are other contraindications for imaging examination of the research plan, such as claustrophobia;\n5. Have a history of other malignant tumors;\n6. Pregnant (pregnancy test positive in screening period) or lactating women;\n7. Other circumstances that the researcher considers inappropriate to participate in this clinical trial."}, 'identificationModule': {'nctId': 'NCT07107633', 'briefTitle': 'A Phase II Clinical Study to Evaluate the Efficacy and Safety of Technetium [99mtc]-H7ND Injection in the Diagnosis of Peritoneal Metastasis of Gastrointestinal Malignant Tumor.', 'organization': {'class': 'OTHER', 'fullName': 'Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.'}, 'officialTitle': 'A Multicenter, Open-access, Self-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Technetium [99mTc]-H7ND Injection in the Diagnosis of Peritoneal Metastasis of Gastrointestinal Malignancies.', 'orgStudyIdInfo': {'id': '2025-024R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with malignant tumors of the gastrointestinal tract', 'interventionNames': ['Drug: Technetium [99mTc]-H7ND injection']}], 'interventions': [{'name': 'Technetium [99mTc]-H7ND injection', 'type': 'DRUG', 'description': 'Technetium \\[99mTc\\]-H7ND injection is a radiolabeled fibroblast activation protein inhibitor', 'armGroupLabels': ['Patients with malignant tumors of the gastrointestinal tract']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongcheng Shi', 'role': 'CONTACT', 'email': 'shi.hongcheng@zs-hospital.sh.cn', 'phone': '021-64041990'}], 'facility': 'Zhongshan Hospital Affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hongcheng Shi', 'role': 'CONTACT', 'email': 'shi.hongcheng@zs-hospital.sh.cn', 'phone': '021-64041990'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}