Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-01 @ 1:06 PM
Study NCT ID:
NCT05815069
Status:
UNKNOWN
Last Update Posted:
2023-08-08
First Post:
2023-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[18F]AlF-NOTA-pentixather PET/CT in Patients With Suspected Primary Hyperaldosteronism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018246', 'term': 'Adrenocortical Adenoma'}], 'ancestors': [{'id': 'D000306', 'term': 'Adrenal Cortex Neoplasms'}, {'id': 'D000310', 'term': 'Adrenal Gland Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000303', 'term': 'Adrenal Cortex Diseases'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-05', 'studyFirstSubmitDate': '2023-03-22', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum standardized uptake value(SUVmax)', 'timeFrame': 'Within a week of completion of imaging', 'description': 'Maximum standardized uptake value of suspicious adrenal lesion on \\[18F\\]AlF-NOTA-pentixather PET/CT'}, {'measure': 'target background ratio(TBR)', 'timeFrame': 'Within a week of completion of imaging', 'description': 'The ratio of SUVmax of adrenal lesions to SUVmean of the liver background and the ratio of SUVmax of adrenal lesions to SUVmean of the contralateral adrenal gland were analyzed in the study as the target background ratio(TBR).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aldosterone-Producing Adenoma']}, 'referencesModule': {'references': [{'pmid': '32206838', 'type': 'RESULT', 'citation': 'Ding J, Zhang Y, Wen J, Zhang H, Wang H, Luo Y, Pan Q, Zhu W, Wang X, Yao S, Kreissl MC, Hacker M, Tong A, Huo L, Li X. Imaging CXCR4 expression in patients with suspected primary hyperaldosteronism. Eur J Nucl Med Mol Imaging. 2020 Oct;47(11):2656-2665. doi: 10.1007/s00259-020-04722-0. Epub 2020 Mar 23.'}, {'pmid': '30042959', 'type': 'RESULT', 'citation': 'Poschenrieder A, Osl T, Schottelius M, Hoffmann F, Wirtz M, Schwaiger M, Wester HJ. First 18F-Labeled Pentixafor-Based Imaging Agent for PET Imaging of CXCR4 Expression In Vivo. Tomography. 2016 Jun;2(2):85-93. doi: 10.18383/j.tom.2016.00130.'}, {'pmid': '29279316', 'type': 'RESULT', 'citation': 'Heinze B, Fuss CT, Mulatero P, Beuschlein F, Reincke M, Mustafa M, Schirbel A, Deutschbein T, Williams TA, Rhayem Y, Quinkler M, Rayes N, Monticone S, Wild V, Gomez-Sanchez CE, Reis AC, Petersenn S, Wester HJ, Kropf S, Fassnacht M, Lang K, Herrmann K, Buck AK, Bluemel C, Hahner S. Targeting CXCR4 (CXC Chemokine Receptor Type 4) for Molecular Imaging of Aldosterone-Producing Adenoma. Hypertension. 2018 Feb;71(2):317-325. doi: 10.1161/HYPERTENSIONAHA.117.09975. Epub 2017 Dec 26.'}]}, 'descriptionModule': {'briefSummary': 'The study was proposed to include 20 patients with clinical suspicion of primary aldosteronism for \\[18F\\]AlF-NOTA-pentixather PET/CT imaging and to analyze the specificity and sensitivity of \\[18F\\]AlF-NOTA-pentixather PET/CT for the diagnosis of APA by comparison with the final pathological findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent hypertension or refractory hypertension (blood pressure \\>140/90 mmHg with a combination of three antihypertensive drugs, including diuretics) with hypokalemia of blood pressure \\>160/100 mmHg.\n* Uncontrollable hypokalemia with or without hypertension. Persistent hypertension or refractory hypertension with blood pressure \\>160/100 mmHg and aldosterone-renin ratio (ARR) ≥30 (ng/dl)/(ng/ml/h).\n* Positive captopril test (≤30% decrease in plasma aldosterone level after captopril administration) is a sufficient but not mandatory condition.\n* Patients with CT showing unilateral or bilateral adrenal nodules with well-defined borders but normal serum potassium and ARR \\<30 (ng/dl)/(ng/ml/h) were also included in the study.\n\nExclusion Criteria:\n\n* Female patients who are pregnant (or intend to become pregnant within six months), breastfeeding, or unwilling to use contraception.\n* Abnormal cardiopulmonary function or mental status, unable to tolerate prone for 20 minutes.\n* Refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved study protocol.\n* Other conditions deemed by the investigator to be inappropriate for participation in this study.'}, 'identificationModule': {'nctId': 'NCT05815069', 'briefTitle': '[18F]AlF-NOTA-pentixather PET/CT in Patients With Suspected Primary Hyperaldosteronism', 'organization': {'class': 'OTHER', 'fullName': "Sichuan Provincial People's Hospital"}, 'officialTitle': 'Clinical Study of Chemokine Receptor 4 (CXCR4)-Mediated Precision Targeting of 18F for the Diagnosis of Aldosteronism in Primary Aldosteronism', 'orgStudyIdInfo': {'id': 'SCPHNM2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[18F]AlF-NOTA-pentixather', 'description': "No special preparation such as fasting and fasting is required before the examination. The radiotracer 18F-AlF-NOTA-pentiaxther PET/CT (dose 4.81 MBq/Kg body weight) was injected intravenously according to the patient's body weight, and the drug was synthesized by the Department of Nuclear Medicine of Sichuan Provincial People's Hospital immediately before the examination. Before the examination, patients were instructed to urinate as many times as possible to reduce the possible influence of the residual radiotracer in the renal pelvis and calyces on the image quality. The whole-body PET/CT examination from the top of the skull to the root of the thigh was performed using a PET/CT examination instrument (Siemens Biograph mCT Flow) 50-60 minutes after the injection of radiopharmaceuticals. Flow Motion flow scanning technology with a matrix of 128x128 and a layer thickness of 3 mm was used. all PET images were reconstructed iteratively.", 'interventionNames': ['Diagnostic Test: [18F]AlF-NOTA-pentixather PET/CT']}], 'interventions': [{'name': '[18F]AlF-NOTA-pentixather PET/CT', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['pathological examination'], 'description': "The radiotracer 18F-AlF-NOTA-pentixather PET/CT (dose 4.81 MBq/Kg body weight) was injected intravenously according to the patient's body weight. The whole-body PET/CT examination from the top of the skull to the root of the thigh was performed using a PET/CT examination instrument (Siemens Biograph mCT Flow) 50-60 minutes after the injection of radiopharmaceuticals. Flow Motion flow scanning technology with a matrix of 128x128 and a layer thickness of 3 mm was used. all PET images were iteratively reconstructed. Patients who have undergone surgery routinely undergo pathological examination.", 'armGroupLabels': ['[18F]AlF-NOTA-pentixather']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Zhang, Ph.D', 'role': 'CONTACT', 'email': 'zhangwscd@uestc.edu.cn', 'phone': '86+02887393368'}, {'name': 'Limeng He, MA.Sc', 'role': 'CONTACT', 'email': 'hlmxnykdx@163.com'}], 'facility': "Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Wei Zhang, Ph.D', 'role': 'CONTACT', 'email': 'zhangwscd@uestc.edu.cn', 'phone': '86+02887393368'}, {'name': 'Limeng He, MA.Sc', 'role': 'CONTACT', 'email': 'hlmxnykdx@163.com', 'phone': '86+17311397283'}], 'overallOfficials': [{'name': 'Wei Zhang, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Sichuan Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Sichuan Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate senior physician', 'investigatorFullName': 'Hao Wang', 'investigatorAffiliation': "Sichuan Provincial People's Hospital"}}}}