Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-30 @ 9:08 PM
Study NCT ID:
NCT01310192
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2009-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2009-06-24', 'studyFirstSubmitQcDate': '2011-03-04', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis', 'timeFrame': 'Immediate - no longitudinal data collected'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '17607041', 'type': 'BACKGROUND', 'citation': 'DeGrado TR, Kwee SA, Coel MN, Coleman RE. The impact of urinary excretion of (18)F-labeled choline analogs. J Nucl Med. 2007 Jul;48(7):1225. doi: 10.2967/jnumed.107.040667. No abstract available.'}, {'pmid': '15592091', 'type': 'BACKGROUND', 'citation': 'Kwee SA, Coel MN, Lim J, Ko JP. Prostate cancer localization with 18fluorine fluorocholine positron emission tomography. J Urol. 2005 Jan;173(1):252-5. doi: 10.1097/01.ju.0000142099.80156.85.'}, {'pmid': '18384719', 'type': 'RESULT', 'citation': 'Kwee SA, Thibault GP, Stack RS, Coel MN, Furusato B, Sesterhenn IA. Use of step-section histopathology to evaluate 18F-fluorocholine PET sextant localization of prostate cancer. Mol Imaging. 2008 Jan-Feb;7(1):12-20.'}, {'pmid': '17920349', 'type': 'RESULT', 'citation': 'Kwee SA, DeGrado TR, Talbot JN, Gutman F, Coel MN. Cancer imaging with fluorine-18-labeled choline derivatives. Semin Nucl Med. 2007 Nov;37(6):420-8. doi: 10.1053/j.semnuclmed.2007.07.003.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to develop and evaluate fluorine-18 (F-18) fluorocholine (FCH) positron emission tomography (PET) as an imaging technique that can be used to delineate malignant tumors in the prostate gland. The proposed technique works by measuring the tissue metabolism of FCH, a substrate that is preferentially metabolized by cancer cells due to malignant over-expression of the choline transporter and choline kinase enzyme. The project scope covers a clinical study to recruit men with prostate cancer who have elected treatment by radical prostatectomy surgery. These men will undergo pre-operative PET scanning to measure F-18 FCH uptake in anatomical sextants of the prostate gland. Imaging results will be compared to histopathologic analyses of the prostatectomy specimen to determine the accuracy of F-18 FCH PET for detecting cancerous prostate sextants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy\n\nExclusion Criteria:\n\n* Weight \\> 300 lb'}, 'identificationModule': {'nctId': 'NCT01310192', 'briefTitle': 'Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography', 'organization': {'class': 'OTHER', 'fullName': "Queen's Medical Center"}, 'officialTitle': 'Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography', 'orgStudyIdInfo': {'id': 'RA-2004-040'}, 'secondaryIdInfos': [{'id': 'PC04130'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Investigational Imaging Device', 'interventionNames': ['Device: Fluourine-18 Fluoromethylcholine PET/CT Imaging']}], 'interventions': [{'name': 'Fluourine-18 Fluoromethylcholine PET/CT Imaging', 'type': 'DEVICE', 'otherNames': ['18F-choline PET/CT', 'Fluorocholine PET/CT'], 'description': 'Single-dose Study', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tripler AMC', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Tripler Army Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's Medical Center", 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}