Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-01-07 @ 9:16 AM
Study NCT ID:
NCT06919159
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2025-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intratumoral Heterogeneity on [18F]PSMA and [18F]FDG PET/CT in Predicting Invasion and Prognosis of Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The relationship between imaging phenotypes and gleason score (GS)', 'timeFrame': 'From enrollment to the end of 1 month inspection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluorine-18-fluorodeoxyglucose', 'Heterogeneity'], 'conditions': ['Prostate Cancer (Diagnosis)', 'Prostate-specific Membrane Antigen', 'Positron Emission Tomography (PET)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyze heterogeneity of prostate cancer（PCa）based on the head-to-head imaging of prostate-specific membrane antigen (PSMA) and fluorodeoxyglucose (FDG) positron emission tomography computed tomography (PET/CT)', 'detailedDescription': 'PET/CT examinations were performed on different days using Siemens Biograph MCT PET/CT equipment. All patients were examined on the same scanner. Patients were fasted for more than 6 h before \\[18F\\]FDG PET/CT examination, blood glucose was controlled below 11.1 mmol/L, \\[18F\\]FDG injection dose was 3.7 MBq/kg, and \\[18F\\]FDG PET/CT examination was performed after 60 min rest. \\[18F\\]PSMA-1007 injection dose was 3.7 MBq/kg, and PET/CT scan was performed 60 min after injection. To avoid interference of prostate lesion detection by active urine in the bladder, patients were asked to urinate or undergo forced diuresis before the start of the examination. The scan was performed from the top of the head to the base of the thighs. Low-dose CT was taken with automatic milliampere-second 120 kV voltage scans with a matrix of 512 × 512 and a thickness of 5 mm, and PET/CT image acquisition was taken from 5-6 beds for 2-3 min each. CT data was used for attenuation correction at the end of the acquisition, reconstructed by the two-iteration method (21 subsets in total), and the True X +TOF algorithm was applied to reconstruct the images. Two nuclear medicine physicians with extensive experience in PET/CT interpretation evaluated the images using the LIFEx software v 7.1.0. Both readers were blinded to both clinical and pathological data'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects treated at the First Affiliated Hospital of China Medical University', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Untreated patients with PCa confirmed by prostate systemic pathological biopsy\n* Patients underwent \\[18F\\]PSMA-1007 and \\[18F\\]FDG PET/CT and the imaging interval was less than one month.\n\nExclusion Criteria:\n\n* Patients received treatment at intervals of two imaging\n* Imaging was less than 1 week after pathology biopsy'}, 'identificationModule': {'nctId': 'NCT06919159', 'briefTitle': 'Intratumoral Heterogeneity on [18F]PSMA and [18F]FDG PET/CT in Predicting Invasion and Prognosis of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'First Hospital of China Medical University'}, 'officialTitle': 'Intratumoral Heterogeneity on [18F]PSMA-1007 and [18F]FDG PET/CT in Predicting Invasion and Prognosis of Primary Prostate Cancer', 'orgStudyIdInfo': {'id': '[2020]388'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'double positive group', 'description': 'patients with one type of PSMA+/FDG+ homogeneous segment', 'interventionNames': ['Diagnostic Test: PSMA PET/CT scan', 'Diagnostic Test: FDG-PET']}, {'label': 'double negative group', 'description': 'patients with one type of PSMA-/FDG- homogeneous segment', 'interventionNames': ['Diagnostic Test: PSMA PET/CT scan', 'Diagnostic Test: FDG-PET']}, {'label': 'PSMA predominant group', 'description': 'patients with one type of PSMA+/FDG- heterogeneous segment', 'interventionNames': ['Diagnostic Test: PSMA PET/CT scan', 'Diagnostic Test: FDG-PET']}, {'label': 'FDG predominant group', 'description': 'patients with one type of PSMA-/FDG+ heterogeneous segment', 'interventionNames': ['Diagnostic Test: PSMA PET/CT scan', 'Diagnostic Test: FDG-PET']}], 'interventions': [{'name': 'PSMA PET/CT scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Different developing agents', 'armGroupLabels': ['FDG predominant group', 'PSMA predominant group', 'double negative group', 'double positive group']}, {'name': 'FDG-PET', 'type': 'DIAGNOSTIC_TEST', 'description': 'Different developing agents', 'armGroupLabels': ['FDG predominant group', 'PSMA predominant group', 'double negative group', 'double positive group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Department of Nuclear Medicine, The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Xuena Li, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Hospital of China Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiequn Yu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Jiequn Yu', 'investigatorAffiliation': 'First Hospital of China Medical University'}}}}