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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 99mTc-NTP 15-5 (level 1) | Experimental | 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg |
|
| 99mTc-NTP 15-5 (level 2) | Experimental | 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg |
|
| 99mTc-NTP 15-5 (level 3) | 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 5 MBq/kg | Drug | 1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg (D0) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) | 1 week after injection of the 99mTc-NTP 15-5 (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5 |
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Inclusion Criteria:
Inclusion criteria specific to group 1:
- Patient with painful unilateral osteoarthritis of the knee as femorotibial pattern defined by a radiographic score of 0/1 from Kellgren / Lawrence and an average WOMAC score> or equal to 4 and by minor disorders at MRI (MOCART 2.0 score> 70).
Inclusion criteria specific to group 2:
Common inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florent CACHIN, Pr | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France | |||
| CHU Clermont-Ferrand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41003883 | Derived | Chanchou M, Thivat E, Mathieu S, Levesque S, Sas N, Auzeloux P, Billoux T, Molnar I, Jouberton E, Rouanet J, Fois G, Maigne L, Penault-Llorca F, Miot-Noirault E, Durando X, Cachin F. [99mTc]Tc-NTP 15 - 5, a new proteoglycan tracer for functional imaging of joint cartilage: phase I (CARSPECT). EJNMMI Res. 2025 Sep 26;15(1):123. doi: 10.1186/s13550-025-01318-3. | |
| 36314021 |
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dose escalation model
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| 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg | Drug | 1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg (D0) |
|
| 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) |
|
| Safety of 99mTc-NTP 15-5 (frequence of adverse events) | according to the NCI-CTCAE (version 4.03) | 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. | 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) | radiation counting on whole blood and on plasma | 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 | 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 | 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 | 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. | imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5 |
| Clermont-Ferrand |
| France |
| Thivat E, Chanchou M, Mathieu S, Levesque S, Billoux T, Auzeloux P, Sas N, Molnar I, Jouberton E, Rouanet J, Fois G, Maigne L, Galmier MJ, Penault-Llorca F, Miot-Noirault E, Durando X, Cachin F. Assessment of 99mTc-NTP 15-5 uptake on cartilage, a new proteoglycan tracer: Study protocol for a phase I trial (CARSPECT). Front Med (Lausanne). 2022 Oct 12;9:993151. doi: 10.3389/fmed.2022.993151. eCollection 2022. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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