Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-31 @ 11:51 AM
Study NCT ID:
NCT06756334
Status:
RECRUITING
Last Update Posted:
2025-01-03
First Post:
2024-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572626', 'term': '2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-25', 'studyFirstSubmitDate': '2024-12-25', 'studyFirstSubmitQcDate': '2024-12-25', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard uptake value(SUV)', 'timeFrame': '30 days', 'description': 'Standard uptake value(SUV) of \\[18F\\]AlF-PSMA-N5 and \\[18F\\]F-DCFPyL for each target lesion of subjects.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic efficacy', 'timeFrame': '30 days', 'description': 'The sensitivity, specificity and accuracy of \\[18F\\]AlF-PSMA-N5 and \\[18F\\]F-DCFPyL PET/CT were calculated.'}, {'measure': 'Number of lesions', 'timeFrame': '30 days', 'description': 'The number of lesions detected by \\[18F\\]AlF-PSMA-N5 and \\[18F\\]F-DCFPyL PET/CT.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'PET/CT']}, 'descriptionModule': {'briefSummary': 'To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \\[18F\\]AlF-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \\[18F\\]F-DCFPyL.', 'detailedDescription': '\\[18F\\]AlF-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \\[18F\\]F-DCFPyL PET/CT.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged from 18 to 90 years old;\n* Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);\n* Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;\n* simultaneous \\[18F\\]AlF-PSMA-N5 and \\[18F\\]F-DCFPyL examinations within two weeks;\n* Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;\n* Sign informed consent.\n\nExclusion Criteria:\n\n* Patients who cannot cooperate with the examination;\n* Concurrent malignant tumors;\n* Previous alcohol allergy;\n* Patients with liver and kidney dysfunction;\n* Other circumstances deemed by the investigator to be inappropriate for trial participation.'}, 'identificationModule': {'nctId': 'NCT06756334', 'briefTitle': 'Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and Metastasis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Anhui Provincial Hospital'}, 'officialTitle': 'Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study', 'orgStudyIdInfo': {'id': 'PSMA PET STUDY -03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/ CT scan', 'description': 'Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of \\[18F\\]AlF-PSMA-N5 and \\[18F\\]F-DCFPyL.', 'interventionNames': ['Drug: [18F]AlF-PSMA-N5', 'Drug: [18F]F-DCFPyL']}], 'interventions': [{'name': '[18F]AlF-PSMA-N5', 'type': 'DRUG', 'description': 'Each subject receive a single intravenous injection of \\[18F\\]AlF-PSMA-N5, and undergo PET/CT imaging within the specificed time.', 'armGroupLabels': ['[18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/ CT scan']}, {'name': '[18F]F-DCFPyL', 'type': 'DRUG', 'description': 'Each subject receive a single intravenous injection of \\[18F\\]F-DCFPyL, and undergo PET/CT imaging within the specificed time.', 'armGroupLabels': ['[18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/ CT scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Xie, MD', 'role': 'CONTACT', 'email': 'xieqiang1980@ustc.edu.cn', 'phone': '13721108043'}], 'facility': 'The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Qiang Xie, MD', 'role': 'CONTACT', 'email': 'xieqiang1980@ustc.edu.cn', 'phone': '13721108043'}], 'overallOfficials': [{'name': 'Qiang Xie, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}