99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Drug1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)
NCT Number: NCT07624994
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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Get Notified18 year and older
All sexes
Interventional
Phase 2
Centre Jean Perrin, Clermont-Ferrand, PUY DE DOME, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
RA Group:
Group DOA:
Exclusion criteria
RA Group:
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)
Time frame: 2 hour after injection
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.
Time frame: 2 hours after injection of 99mTc-NTP 15-5
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.
Time frame: 2 hours after injection
Performance measures of 99mTc-NTP 15-5 imaging to detect an affected joint complex
Time frame: 2 hours after injection
The proportion of joints classified as pathological, according to the scintigraphic method and the radioclinical method
Time frame: 2 hours after injection
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.
Time frame: 2 hours after injection
Inter-observer reproducibility measures: Cohen's kappa coefficient for visual readings (before to consensus) and intra-class correlation coefficient (ICC) for quantitative readings.
Time frame: 2 hours after injection
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.
Time frame: during 1 week after injection 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.
Contact information is provided by the study sponsor or research team.
Centre Jean Perrin
Other
Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine: Phase II Clinical Study
Acronym: CARSPECT II
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