99mTc-labelled D-Glucosamine in the Evaluation of Disease Activity in Patients With Degenerative and Inflammatory Rheumatic Conditions
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Aim 1. To evaluate the role of 99mTc-ECDG in Rheumatoid Arthritis (RA). Both as a monitoring and diagnostic tool.
Approach. Three separate cohorts of patients suffering from RA will be recruited;
- Patients with newly diagnosed RA;
- Patients with active and long-standing RA before and after treatment with anti-TNF;
- Patients with RA in remission with or without anti-TNF treatment.
5-10 patients will be recruited into each cohort. In order to provide written consent all patients will be older than 18 years old. 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. No restrictions will be imposed on the treatment patients are able to receive for their underlying rheumatic condition, nor for any other medical condition while in this study. Patients will be required to cease any glucosamine therapy for three days prior to the injection of the radiotracer.
An evaluation of patient's history and physical examination will be conducted prior to tracer administration. All relevant disease will be documented as well as concurrent illnesses and treatment regimes. A rheumatologist will assess disease severity and documented as per recommendations outlined under the PBS guidelines for subsidised treatment (HIC - Medicare Australia). Biological markers of disease will be acquired from each patient at the time of clinical assessment, including ESR, CRP levels, rheumatoid factor and anti-citrullinated peptide antibodies. Similar assessments will be undertaken at six monthly intervals for three years. These results will be used to correlate with the scan findings. Patients from cohort A & B will have their initial scans acquired prior to the commencement of therapy. Scans will be repeated six months later in all patients. Results will be analysed on both a per patient basis and a per joint basis.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.