This study is a phase I clinical trial aimed to determine the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
6
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg (D0)
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg (D0)
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)
Centre Jean Perrin
Clermont-Ferrand, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
determination of the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity
defined as the dose from which 100% of patients will present a score 3 (semi-quantitative visual scale on whole body imaging) in at least 80% of healthy joints visualized on scintigraphies performed 2 h or less post-injection and without dose-limiting toxicity (DLT).
Time frame: Imaging at Day 0 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours post-injection)
dose-limiting toxicity (DLT)
defined as any grade 3-4 toxicity according to the NCI-CTCAE (version 4.03)
Time frame: 1 week after injection of the 99mTc-NTP 15-5 (Day 0)
3D quantification analysis
TEMP Volumetric regions of interest (VOI) will be centered on cartilaginous zones, and on the corresponding bony diaphyses or vertebral body or the adjacent muscles. The articular uptake of 99mTc NTP-15-5 will thus be normalized to bone or muscle uptake.
Time frame: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
Safety of 99mTc-NTP 15-5 (frequence of adverse events)
according to the NCI-CTCAE (version 4.03)
Time frame: 1 week after injection of the 99mTc-NTP 15-5 (Day 0)
Biodistribution of 99mTc-NTP 15-5
evaluated by measuring the percentage of injected activity of 99mTc-NTP 15-5 fixed on the target organs and on the pathological joints or healthy joints.
Time frame: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Area Under the Curve (AUC)
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radiation counting on whole blood and on plasma
Time frame: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Maximum Concentration (Cmax)
radiation counting on whole blood and on plasma
Time frame: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of the time take to reach Cmax (Tmax)
radiation counting on whole blood and on plasma
Time frame: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Urinary elimination of 99mTc-NTP 15-5
by counting
Time frame: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Dosimetry
measurement of the absorbed dose per organ will be evaluated by quantitative analysis.
Time frame: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5