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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01789151
Registration number
NCT01789151
Ethics application status
Date submitted
7/02/2013
Date registered
11/02/2013
Date last updated
31/10/2016
Titles & IDs
Public title
99m-Technetium- Glucosamine in Arthritis
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Scientific title
99mTc-labelled D-Glucosamine in the Evaluation of Disease Activity in Patients With Degenerative and Inflammatory Rheumatic Conditions
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Secondary ID [1]
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IMM 11-0091
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Secondary ID [2]
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Glucosamine
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Ankylosing Spondylitis
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Expanded Access
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Description of intervention(s) / exposure
Treatment: Devices - Technetium labelled glucosamine
Treatment: Devices: Technetium labelled glucosamine
Nuclear medicine imaging of arthritic joints using radioactive glucosamine
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
* In order to provide written consent all patients will be older than 18 years old. Patients with RA need to satisfy the ACR criteria. Similarly for AS patients need to satisfy current criteria for the diagnosis.
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Minimum age
18
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Maximum age
90
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Exclusion criteria will include any patient with an allergy to glucosamine or seafood, any patient with end-stage renal or hepatic disease, pregnancy or lactation. Patients with previous history of malignancy, TB, Hep B, Hep C, AIDS will be excluded.
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Study design
Purpose of the study
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Allocation to intervention
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Phase
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Recruitment
Recruitment status
NO_LONGER_AVAILABLE
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Data analysis
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Date of first participant enrolment
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Date of last participant enrolment
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Sample size
Target
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Sydney
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Recruitment postcode(s) [1]
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2145 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Name [1]
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AbbVie
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Address [1]
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Ethics approval
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Summary
Brief summary
Preliminary data following a pilot study from our institution confirms the ability of 99mTc-glucosamine (99mTc-ECDG) to differentiate between active, subclinical and quiescent disease in patients with rheumatoid arthritis, scleroderma lung, and vasculitis. We propose to extend these findings and further evaluate this imaging modality for its clinical utility, limitations, and application. An unacceptably high level of morbidity exists amongst patients suffering from rheumatic disease. This is often the result of mild disease being missed or misdiagnosed, and therapy inordinately delayed or inappropriate. The currently used therapeutic agents themselves have associated side-effects adding to unfavourable clinical outcomes. There is therefore a need for a superior, less expensive and more easily accessible imaging modality to assess the degree of inflammation to guide the clinician. Glucosamine is absorbed and metabolised in a manner not too dissimilar to that of glucose, and it can be readily labelled to form 99mTc-ECDG. Scans can be acquired within 3 hours of intravenous administration of this agent, accurately depicting sites of active inflammation/disease. HYPOTHESIS Glucose is a vital cellular substrate that accumulates at inflamed tissues because of the greater metabolic needs of the cells during active disease. Glucosamine, being an analogue of glucose, is metabolised more quickly in inflamed than non-inflamed tissue and thus 99mTc-ECDG scintigraphy like 18-Fluorodeoxyglucose (18FDG-PET) scintigraphy allows for detection of active inflammation. Unlike current bone scans this agent has the sensitivity to detect subclinical inflammatory disease that would in turn provide essential information to ensure accurate diagnosis and treatment.
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Trial website
https://clinicaltrials.gov/study/NCT01789151
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Nicholas Manolios, MD, Phd
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Address
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University of Sydney / Westmead Hospital
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01789151
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