99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
Drug1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg (D0)
NCT Number: NCT04481230
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.
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Notify Me18 year–60 year
All sexes
Interventional
Early Phase 1
CHU Clermont-Ferrand, Clermont-Ferrand, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
specific to group 1:
Inclusion criteria
specific to group 2:
Common inclusion criteria:
Exclusion criteria
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)
Time frame: Imaging at Day 0 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours post-injection)
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: 1 week after injection of the 99mTc-NTP 15-5 (Day 0)
defined as any grade 3-4 toxicity according to the NCI-CTCAE (version 4.03)
Time frame: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
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: 1 week after injection of the 99mTc-NTP 15-5 (Day 0)
according to the NCI-CTCAE (version 4.03)
Time frame: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 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: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
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
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
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
by counting
Time frame: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
measurement of the absorbed dose per organ will be evaluated by quantitative analysis.
Centre Jean Perrin
Other
Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer: Phase I Clinical Trial
Acronym: CARSPECT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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