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This study is a phase Ii clinical trial aimed to evaluate the performance of 99mTc-NTP 15-5 to identify a pathological hand joint in each group ; digital osteoarthrosis and rheumatoid arthritis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid arthritis | Experimental | 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg |
|
| digital osteoarthritis | Experimental | 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg | Drug | 1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0) |
|
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the performance of 99mTc-NTP 15-5 to identify a pathological hand joint in each group: digital osteoarthritis (DOA) and rheumatoid arthritis (RA) | The diagnostic accuracy of 99mTc-NTP 15-5 imaging in detecting an abnormal joint among the 15 joints of the hands. The scintigraphic analysis of the joints will be visual, blinded to the pathology, and binary in nature. A joint will be considered pathological on 99mTc-NTP 15-5 in the event of abnormal tracer uptake, compared to joints with physiological uptake. The diagnosis of a pathological joint (gold standard) will be based on a composite radiological-clinical analysis. | 2 hour after injection |
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the diagnostic performance of 99mTc-NTP 15-5 for differential diagnosis between DAO and RA. | Performance measures of 99mTc-NTP 15-5 imaging for distinguishing between DAO and RA. Readers will classify the scintigrams as DAO or RA based on the uptake pattern. A consensus will be sought in cases of disagreement. The gold standard will be the diagnosis determined by radioclinical analysis. |
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Inclusion Criteria:
RA Group:
Group DOA:
Exclusion Criteria:
RA Group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion CHANCHOU, Dr | Contact | 33473278089 | marion.chachou@clermont.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marion CHANCHOU, Dr | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Clermont-Ferrand | PUY DE DOME | 63011 | France |
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| 2 hours after injection of 99mTc-NTP 15-5 |
| to evaluate the performance of 99mTc-NTP imaging 15-5 by joint group in each pathology. | Performance measures of 99mTc-NTP 15-5 imaging to detect an affected joint complex | 2 hours after injection |
| to determine the prevalence of joint damage by pathology according to the scintigraphic method and the radioclinical method | The proportion of joints classified as pathological, according to the scintigraphic method and the radioclinical method | 2 hours after injection |
| To quantitatively analyze the fixation of 99mTc-NTP 15-5 on the hand joints, in each pathology. | measurements of the joint/radial diaphysis ration (99mTc-NTP 15-5A/D), determined by semi-automatic contouring joint interfaces on tomoscintigraphic images and manually traced spherical region of interest on radial diaphyses. | 2 hours after injection |
| to evaluate the inter-observer reproducibility of visual and quantitative readings | Inter-observer reproducibility measures: Cohen's kappa coefficient for visual readings (before to consensus) and intra-class correlation coefficient (ICC) for quantitative readings. | 2 hours after injection |
| to describe the fixation of 99mTc-NTP 15-5 on skeletal joints other than hand joints, based on visual analysis. | All skeletal joints other than the hands will be rated by a score : 0: no fixation, 1: fixation < adjacent diaphysis, 2: fixation = adjacent diaphysis, 3: fixation > adjacent diaphysis. | 2 hours after injection |
| to evaluate the tolerance of 99mTc-NTP 15-5. | Adverse events (AEs) assessed according to the NCI-CTCAE V5.0 criteria and associated with 99mTc-NTP 15-5 occurring within the week following the injection. | during 1 week after injection of 99mTc-NTP 15-5 |
| Chu Clermont Ferrand | Clermont-Ferrand | France |
|
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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