99m-Technetium- Glucosamine in Arthritis

NCT01789151 | Unknown

• 2 other identifiers: GlucosamineIMM 11-0091
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis

Keywords

arthritis; nuclear imaging; rheumatoid; ankylosing spondylitis; glucosamine

Interventions

Technetium labelled glucosamine DEVICE

Nuclear medicine imaging of arthritic joints using radioactive glucosamine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Sydney: lead
• AbbVie: collaborator

Study Sites (1)

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis

Study Officials

• Nicholas Manolios, MD, Phd

  University of Sydney / Westmead Hospital

  PRINCIPAL INVESTIGATOR

• Nicholas Manolios

  University of Sydney / Westmead Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

AU (1)