Rheumatoid Arthritis Clinical Trial
Official title:
99mTc-labelled D-Glucosamine in the Evaluation of Disease Activity in Patients With Degenerative and Inflammatory Rheumatic Conditions
NCT number | NCT01789151 |
Other study ID # | Glucosamine |
Secondary ID | IMM 11-0091 |
Status | No longer available |
Phase | N/A |
First received | February 7, 2013 |
Last updated | October 27, 2016 |
Verified date | October 2016 |
Source | University of Sydney |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: Human Research Ethics Committee |
Study type | Expanded Access |
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.
Status | No longer available |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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. 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. |
N/A
Country | Name | City | State |
---|---|---|---|
Australia | Westmead Hospital | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
University of Sydney | AbbVie |
Australia,
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