Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 1:46 PM
Study NCT ID:
NCT00354003
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2006-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of the Impact of Disclosing Imaging Study Information to Trial Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2006-07-17', 'studyFirstSubmitQcDate': '2006-07-17', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06-27', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Parkinson', 'Imaging'], 'conditions': ['Parkinsonian Syndrome', 'Parkinson']}, 'referencesModule': {'references': [{'pmid': '8998140', 'type': 'BACKGROUND', 'citation': "Asenbaum S, Brucke T, Pirker W, Podreka I, Angelberger P, Wenger S, Wober C, Muller C, Deecke L. Imaging of dopamine transporters with iodine-123-beta-CIT and SPECT in Parkinson's disease. J Nucl Med. 1997 Jan;38(1):1-6."}, {'pmid': '10768556', 'type': 'BACKGROUND', 'citation': "Mozley PD, Schneider JS, Acton PD, Plossl K, Stern MB, Siderowf A, Leopold NA, Li PY, Alavi A, Kung HF. Binding of [99mTc]TRODAT-1 to dopamine transporters in patients with Parkinson's disease and in healthy volunteers. J Nucl Med. 2000 Apr;41(4):584-9."}, {'pmid': '9829575', 'type': 'BACKGROUND', 'citation': "Booij J, Habraken JB, Bergmans P, Tissingh G, Winogrodzka A, Wolters EC, Janssen AG, Stoof JC, van Royen EA. Imaging of dopamine transporters with iodine-123-FP-CIT SPECT in healthy controls and patients with Parkinson's disease. J Nucl Med. 1998 Nov;39(11):1879-84."}, {'pmid': '8265656', 'type': 'BACKGROUND', 'citation': 'Innis RB, Seibyl JP, Scanley BE, Laruelle M, Abi-Dargham A, Wallace E, Baldwin RM, Zea-Ponce Y, Zoghbi S, Wang S, et al. Single photon emission computed tomographic imaging demonstrates loss of striatal dopamine transporters in Parkinson disease. Proc Natl Acad Sci U S A. 1993 Dec 15;90(24):11965-9. doi: 10.1073/pnas.90.24.11965.'}, {'pmid': '1796351', 'type': 'BACKGROUND', 'citation': "Kaufman MJ, Madras BK. Severe depletion of cocaine recognition sites associated with the dopamine transporter in Parkinson's-diseased striatum. Synapse. 1991 Sep;9(1):43-9. doi: 10.1002/syn.890090107."}, {'pmid': '1987318', 'type': 'BACKGROUND', 'citation': 'Niznik HB, Fogel EF, Fassos FF, Seeman P. The dopamine transporter is absent in parkinsonian putamen and reduced in the caudate nucleus. J Neurochem. 1991 Jan;56(1):192-8. doi: 10.1111/j.1471-4159.1991.tb02580.x.'}, {'pmid': '8797470', 'type': 'BACKGROUND', 'citation': "Wilson JM, Levey AI, Rajput A, Ang L, Guttman M, Shannak K, Niznik HB, Hornykiewicz O, Pifl C, Kish SJ. Differential changes in neurochemical markers of striatal dopamine nerve terminals in idiopathic Parkinson's disease. Neurology. 1996 Sep;47(3):718-26. doi: 10.1212/wnl.47.3.718."}, {'pmid': '11535717', 'type': 'BACKGROUND', 'citation': "Huang WS, Lin SZ, Lin JC, Wey SP, Ting G, Liu RS. Evaluation of early-stage Parkinson's disease with 99mTc-TRODAT-1 imaging. J Nucl Med. 2001 Sep;42(9):1303-8."}, {'pmid': '9048712', 'type': 'BACKGROUND', 'citation': "Booij J, Tissingh G, Boer GJ, Speelman JD, Stoof JC, Janssen AG, Wolters EC, van Royen EA. [123I]FP-CIT SPECT shows a pronounced decline of striatal dopamine transporter labelling in early and advanced Parkinson's disease. J Neurol Neurosurg Psychiatry. 1997 Feb;62(2):133-40. doi: 10.1136/jnnp.62.2.133."}, {'pmid': '9593103', 'type': 'BACKGROUND', 'citation': "Fischman AJ, Bonab AA, Babich JW, Palmer EP, Alpert NM, Elmaleh DR, Callahan RJ, Barrow SA, Graham W, Meltzer PC, Hanson RN, Madras BK. Rapid detection of Parkinson's disease by SPECT with altropane: a selective ligand for dopamine transporters. Synapse. 1998 Jun;29(2):128-41. doi: 10.1002/(SICI)1098-2396(199806)29:23.0.CO;2-9."}, {'pmid': '7574455', 'type': 'BACKGROUND', 'citation': "Seibyl JP, Marek KL, Quinlan D, Sheff K, Zoghbi S, Zea-Ponce Y, Baldwin RM, Fussell B, Smith EO, Charney DS, van Dyck C, et al. Decreased single-photon emission computed tomographic [123I]beta-CIT striatal uptake correlates with symptom severity in Parkinson's disease. Ann Neurol. 1995 Oct;38(4):589-98. doi: 10.1002/ana.410380407."}, {'pmid': '8053661', 'type': 'BACKGROUND', 'citation': 'Volkow ND, Fowler JS, Wang GJ, Logan J, Schlyer D, MacGregor R, Hitzemann R, Wolf AP. Decreased dopamine transporters with age in health human subjects. Ann Neurol. 1994 Aug;36(2):237-9. doi: 10.1002/ana.410360218.'}, {'pmid': '11790633', 'type': 'BACKGROUND', 'citation': 'van Dyck CH, Seibyl JP, Malison RT, Laruelle M, Zoghbi SS, Baldwin RM, Innis RB. Age-related decline in dopamine transporters: analysis of striatal subregions, nonlinear effects, and hemispheric asymmetries. Am J Geriatr Psychiatry. 2002 Jan-Feb;10(1):36-43.'}, {'pmid': '12244082', 'type': 'BACKGROUND', 'citation': 'Khan NL, Brooks DJ, Pavese N, Sweeney MG, Wood NW, Lees AJ, Piccini P. Progression of nigrostriatal dysfunction in a parkin kindred: an [18F]dopa PET and clinical study. Brain. 2002 Oct;125(Pt 10):2248-56. doi: 10.1093/brain/awf237.'}, {'pmid': '12815653', 'type': 'BACKGROUND', 'citation': 'Dekker M, Bonifati V, van Swieten J, Leenders N, Galjaard RJ, Snijders P, Horstink M, Heutink P, Oostra B, van Duijn C. Clinical features and neuroimaging of PARK7-linked parkinsonism. Mov Disord. 2003 Jul;18(7):751-7. doi: 10.1002/mds.10422.'}, {'pmid': '10565775', 'type': 'BACKGROUND', 'citation': 'Mozley PD, Acton PD, Barraclough ED, Plossl K, Gur RC, Alavi A, Mathur A, Saffer J, Kung HF. Effects of age on dopamine transporters in healthy humans. J Nucl Med. 1999 Nov;40(11):1812-7.'}, {'pmid': '15390019', 'type': 'BACKGROUND', 'citation': 'Catafau AM, Tolosa E; DaTSCAN Clinically Uncertain Parkinsonian Syndromes Study Group. Impact of dopamine transporter SPECT using 123I-Ioflupane on diagnosis and management of patients with clinically uncertain Parkinsonian syndromes. Mov Disord. 2004 Oct;19(10):1175-82. doi: 10.1002/mds.20112.'}, {'pmid': '15313838', 'type': 'BACKGROUND', 'citation': 'Jennings DL, Seibyl JP, Oakes D, Eberly S, Murphy J, Marek K. (123I) beta-CIT and single-photon emission computed tomographic imaging vs clinical evaluation in Parkinsonian syndrome: unmasking an early diagnosis. Arch Neurol. 2004 Aug;61(8):1224-9. doi: 10.1001/archneur.61.8.1224.'}, {'type': 'BACKGROUND', 'citation': "Whone, A., et al., The REAL-PET study: Slower progression in early Parkinson's disease treated with ropinirole compared with L-Dopa. Neurology, 2002. 58 (suppl3): p. A82-A83."}, {'type': 'BACKGROUND', 'citation': 'Parkinson Study Group, Levodopa and the progression of Parkinson disease. NEMJ, 2004. 351: p. 18-28.'}, {'type': 'BACKGROUND', 'citation': 'Marek, K., J. Seibyl, and Parkinson Study Group, ß-CIT Scans without evidence of dopaminergic deficit (SWEDD) in the ELLDOPA-CIT and CALM-CIT study: long-term imaging assessment. Neurology, 2003. 60 (Suppl 1): p. A298.'}]}, 'descriptionModule': {'briefSummary': 'The overall goal of the study is to evaluate how research participants in Parkinson Disease studies that include brain imaging with a dopamine transporter ligand choose to receive the imaging data and what is the impact of the imaging data information on the management of their symptoms.', 'detailedDescription': 'Research participants who previously underwent ß-CIT imaging will be contacted by the staff at IND to enquire whether they would like to receive their ß-CIT scan data. After signing a Research Participant Information and Consent Form, all research participants will be asked to complete a questionnaire prior to receipt of their imaging data. Those research participants requesting imaging data will be sent their data by IND and may review their data with IND (by phone) and/ or with their study investigator. All research participants will be asked to respond to a second questionnaire after receiving their imaging data and to a third study questionnaire approximately six weeks following receipt of their imaging data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Research participants who previously underwent ß-CIT imaging', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous participation in imaging study as described within the protocol\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00354003', 'briefTitle': 'The Study of the Impact of Disclosing Imaging Study Information to Trial Participants', 'organization': {'class': 'OTHER', 'fullName': 'Institute for Neurodegenerative Disorders'}, 'officialTitle': 'Impact of Disclosure of Dopamine Transporter Imaging Studies in PD Clinical Trials', 'orgStudyIdInfo': {'id': 'IMAG-DIS 01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'A series of questionnaires', 'type': 'BEHAVIORAL', 'description': 'Research participants who previously underwent ß-CIT imaging will be contacted by the staff at IND to enquire whether they would like to receive their ß-CIT scan data. After signing a Research Participant Information and Consent Form, all research participants will be asked to complete a questionnaire prior to receipt of their imaging data. Those research participants requesting imaging data will be sent their data by IND and may review their data with IND (by phone) and/ or with their study investigator. All research participants will be asked to respond to a second questionnaire after receiving their imaging data and to a third study questionnaire approximately six weeks following receipt of their imaging data.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Institute for Neurodegenerative Disorders', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Kenneth Marek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Neurodegenerative Disorders'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Neurodegenerative Disorders', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}