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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
99mTc-labelled D-Glucosamine in the Evaluation of Disease Activity in Patients With Degenerative and Inflammatory Rheumatic Conditions
Secondary ID [1] 0 0
IMM 11-0091
Secondary ID [2] 0 0
Glucosamine
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Ankylosing Spondylitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Devices - Technetium labelled glucosamine

Treatment: Devices: Technetium labelled glucosamine
Nuclear medicine imaging of arthritic joints using radioactive glucosamine
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

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.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
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.

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
No longer available
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01789151
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicholas Manolios, MD, Phd
Address 0 0
University of Sydney / Westmead Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01789151