EJNMMI research · 2025
[99mTc]Tc-NTP 15 - 5, a new proteoglycan tracer for functional imaging of joint cartilage: phase I (CARSPECT).
СтатьяНазвание и аннотация: Перевод в очереди
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Chanchou Marion, Thivat Emilie, Mathieu Sylvain, Levesque Sophie, Sas Nicolas, Auzeloux Philippe, Billoux Tommy, Molnar Ioana, Jouberton Elodie, Rouanet Jacques, Fois Giovanna, Maigne Lydia, Penault-Llorca Frédérique, Miot-Noirault Elisabeth, Durando Xavier, Cachin Florent
Аннотация
BACKGROUND: [99mTc]Tc-NTP 15 - 5 showed affinity for joint cartilage proteoglycans on preclinical studies but has not been tested in humans. This phase I trial (CARPECT: NCT04481230) aims to define the optimal of [99mTc]Tc-NTP 15 - 5 injected activity to obtain the best visual contrast of cartilage, without toxicity. Quantitative analyses of cartilage, periarticular uptakes, biodistribution, pharmacokinetic and dosimetry of this new tracer were also studied.
RESULTS: Between November 2020 and June 2022, five patients with unilateral knee osteoarthritis or breast cancer treated with hormonal therapy inducing cartilage disease were injected with [99mTc]Tc-NTP 15 - 5, at increasing activity levels: 5, 10 and 15 MBq/kg. No major toxicity was reported, according to NCICTC 4.0 scale. With an activity of 15 MBq/Kg, the median rate of joint uptakes higher than diaphysis' one on whole body planar scintigraphy was 80.6% (80.60-85.45) at 2 h p.i. and increased with time. S/N ratio with muscular background measured on SPECT-CT was superior to 3 from 2h30 p.i for cartilage. Uptake evolution depending on time from 1h00 to 6h30 p.i. permitted to discriminate cartilage and pooled proteoglycan structures from background and cartilage from ligaments + tendons for all examination times (p < 0.001), and cartilage from bursa at 1 h p.i. (p < 0.05). Pharmacokinetic, biodistribution and dosimetry were in line with preclinical studies.
CONCLUSIONS: This study confirms the usability and accuracy of [99mTc]Tc-NTP 15 - 5 for cartilage human functional imaging 2 h after injection, at 15 MBq/kg.
TRIAL REGISTRATION: Clinicaltrials.gov: NCT04481230. https://clinicaltrials.gov/ct2/show/NCT04481230 . Registration date: November, 12th, 2020.
RESULTS: Between November 2020 and June 2022, five patients with unilateral knee osteoarthritis or breast cancer treated with hormonal therapy inducing cartilage disease were injected with [99mTc]Tc-NTP 15 - 5, at increasing activity levels: 5, 10 and 15 MBq/kg. No major toxicity was reported, according to NCICTC 4.0 scale. With an activity of 15 MBq/Kg, the median rate of joint uptakes higher than diaphysis' one on whole body planar scintigraphy was 80.6% (80.60-85.45) at 2 h p.i. and increased with time. S/N ratio with muscular background measured on SPECT-CT was superior to 3 from 2h30 p.i for cartilage. Uptake evolution depending on time from 1h00 to 6h30 p.i. permitted to discriminate cartilage and pooled proteoglycan structures from background and cartilage from ligaments + tendons for all examination times (p < 0.001), and cartilage from bursa at 1 h p.i. (p < 0.05). Pharmacokinetic, biodistribution and dosimetry were in line with preclinical studies.
CONCLUSIONS: This study confirms the usability and accuracy of [99mTc]Tc-NTP 15 - 5 for cartilage human functional imaging 2 h after injection, at 15 MBq/kg.
TRIAL REGISTRATION: Clinicaltrials.gov: NCT04481230. https://clinicaltrials.gov/ct2/show/NCT04481230 . Registration date: November, 12th, 2020.