Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT07248033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of SPECT/CT of Bone Scan in Charactarization of Bone Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072098', 'term': 'Single Photon Emission Computed Tomography Computed Tomography'}], 'ancestors': [{'id': 'D015899', 'term': 'Tomography, Emission-Computed, Single-Photon'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure SUVmax and SUVmean of bone lesions using quantitative SPECT/CT.', 'timeFrame': 'Baseline'}, {'measure': 'To compare these values between malignant and degenerative lesions confirmed by clinical, histological, or radiological follow-up.', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'To establish a diagnostic SUV cut-off value that aids in distinguishing between lesion types.', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Lesions']}, 'descriptionModule': {'briefSummary': 'This observational study aims to assess the diagnostic value of SPECT/CT of 99mTc-MDP bone scintigraphy in differentiating begnin from malignant bone lesions. The main question it aims to answer is:\n\n●Can SPECT/CT-derived quantitative parameters (SUVmax, SUVmean) accurately differentiate between begnin and malignant bone lesions in clinical settings? Final diagnostic impression: confirmed by biopsy (if available), or through multidisciplinary radiologic-clinical correlation', 'detailedDescription': 'Bone lesions represent a common diagnostic challenge in oncology and general radiology, as they may be of malignant, benign, or degenerative origin. Accurate differentiation is essential for guiding appropriate management, avoiding unnecessary biopsies or surgeries, and improving patient outcomes.\n\nAmong imaging modalities, 99mTc-methylene diphosphonate (MDP) bone scintigraphy has long been a cornerstone in skeletal evaluation due to its high sensitivity in detecting bone turnover. However, hybrid SPECT/CT imaging, which combines functional and anatomical data, has revolutionized bone imaging by enhancing lesion localization, characterization, and diagnostic specificity.\n\nRecent advances in quantitative SPECT/CT allow the extraction of semi-quantitative parameters, such as the Standardized Uptake Value (SUV), previously limited to PET imaging. These SUV-based parameters have shown promising diagnostic value in distinguishing benign from malignant skeletal lesions.\n\nFor instance, SUVmax thresholds derived from 99mTc-MDP SPECT/CT have been proposed in several studies, with malignant lesions often demonstrating higher uptake than benign ones due to increased osteoblastic activity.\n\nIn resource-limited settings such as Egypt, access to PET/CT remains constrained due to cost and availability, especially outside major urban centers. Consequently, leveraging the diagnostic utility of quantitative SPECT/CT could bridge the gap in skeletal lesion assessment and aid in earlier detection and treatment planning.\n\nTherefore, this study aims to evaluate the diagnostic value of SPECT/CT-derived SUV in differentiating benign and malignant bone lesions at a tertiary center in Upper Egypt. It will analyze the correlation between SUV metrics, lesion morphology, and final diagnosis, contributing to the growing body of evidence supporting quantitative SPECT/CT in musculoskeletal oncology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of patients referred to the Nuclear Medicine Unit at Assiut University, for bone imaging using 99mTc-MDP SPECT/CT due to clinical suspicion of bone lesions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any age referred for 99mTc-MDP SPECT/CT\n* Clinical suspicion of either metastatic or degenerative etiology\n\nExclusion Criteria:\n\n* Case with double malignancies\n* Pregnant patients\n* Severely ill patients'}, 'identificationModule': {'nctId': 'NCT07248033', 'briefTitle': 'Role of SPECT/CT of Bone Scan in Charactarization of Bone Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluating the Role of Single Photon Emission Computed Tomography/Computed Tomography Derived Quantitative Parameters of Bone Scintigraphy in Characterization of Bone Lesions.', 'orgStudyIdInfo': {'id': 'SPECT/CT in bone scan'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SPECT/CT', 'type': 'DEVICE', 'description': "It is a medical imaging test that combines a Single-Photon Emission Computed Tomography (SPECT) scan with a Computed Tomography (CT) scan to provide both detailed physiological (function) and anatomical (structure) information about the body. A radioactive tracer is injected and detected by the SPECT camera to show organ function, while the CT scan captures precise images of the body's structures, allowing for precise localization of the tracer and identification of abnormalities in a single, comprehensive study."}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'MennaTalla Saber Sabet', 'role': 'CONTACT', 'email': 'Sebastian.kuroshitsuji1@gmail.com', 'phone': '01151322001'}, {'name': 'Walaa Oteify, Lecturer', 'role': 'CONTACT', 'email': 'walaa@med.aun.edu.eg', 'phone': '01029304463'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MennaTalla Saber Sabet Mohamed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'MennaTalla Saber Sabet Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}