Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine (CARSPECT II)
8. juli 2026 oppdatert av: Centre Jean Perrin
Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine: Phase II Clinical Study
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
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Marion CHANCHOU, Dr
- Telefonnummer: 33473278089
- E-post: marion.chachou@clermont.unicancer.fr
Studiesteder
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Clermont-Ferrand, Frankrike
- Chu Clermont Ferrand
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Ta kontakt med:
- SYLVAIN MATHIEU
- Telefonnummer: MD
- E-post: smathieu@chu-clermontferrand.fr
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PUY DE DOME
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Clermont-Ferrand, PUY DE DOME, Frankrike, 63011
- Centre Jean Perrin
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Ta kontakt med:
- MARION CHANCHOU, MD
- Telefonnummer: 04 73 27 82 01
- E-post: Marion.chanchou@clermont.unicancer.fr
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Karnofsky index > 70%
- Obtaining written, signed and dated informed consent
- Affiliation to a health insurance plan
- For women of childbearing age (fertile, after menarche and until postmenopausal unless sterile after surgery) including on GnRH agonist for ovarian suppression: serum pregnancy test negative at baseline (within 7 days before injection of 99mTc-NTP 15-5). Menopause is defined as amenorrhea for at least 12 consecutive months with no other cause and FSH and oestradiol levels consistent with those of the post-menopausal period.
- Ability and willingness to respect study visits, exams as well as protocol.
RA Group:
- certain diagnosis of rheumatoid arthritis less than 5 years old, according to the ACR/EULAR criteria,
- symptomatic (finger pain > 4 /10 on a numerical scale),
- active synovitis (clinical and ultrasound),
Group DOA:
- certain diagnosis of symptomatic DOA less than 5 years old (finger pain > 4 /10 on a numerical scale),
- stopping NSAIDs for at least 8 days before the injection,
Exclusion Criteria:
- Ongoing use of non-steroidal anti-inflammatory drugs,
- Treatment by local joint corticoid infiltration at the hand level in the month preceding the administration of 99mTc-NTP 15-5,
- History of osteoarticular hand surgery.
- History of hand soft tissue surgery in the past 6 months
- Patients or patients 18 years old,
- Pregnant or breastfeeding patient,
- IMC>30,
- History of known allergy to excipients contained in the 99mTc-NTP 15-5 solution,
- Persons deprived of their liberty, under guardianship/curatorship, or safeguarding of justice,
- Inability to submit to the medical follow-up of the trial for geographical, family, social or psychological reasons. These conditions must be discussed with the patient before registration in the study.
RA Group:
- Use of biotherapies (anti-TNF alpha, rituximab, abatacept, anti-IL6 and anti-JAK) as background treatment.
- Patients with a history of hand DOA
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Rheumatoid arthritis
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
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1 intravenøs injeksjon av 99mTc-NTP 15-5 ved en diagnostisk aktivitet på 15 MBq/kg (D0)
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Eksperimentell: digital osteoarthritis
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
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1 intravenøs injeksjon av 99mTc-NTP 15-5 ved en diagnostisk aktivitet på 15 MBq/kg (D0)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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to evaluate the performance of 99mTc-NTP 15-5 to identify a pathological hand joint in each group: digital osteoarthritis (DOA) and rheumatoid arthritis (RA)
Tidsramme: 2 hour after injection
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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.
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2 hour after injection
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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to evaluate the diagnostic performance of 99mTc-NTP 15-5 for differential diagnosis between DAO and RA.
Tidsramme: 2 hours after injection of 99mTc-NTP 15-5
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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. |
2 hours after injection of 99mTc-NTP 15-5
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to evaluate the performance of 99mTc-NTP imaging 15-5 by joint group in each pathology.
Tidsramme: 2 hours after injection
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Performance measures of 99mTc-NTP 15-5 imaging to detect an affected joint complex
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2 hours after injection
|
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to determine the prevalence of joint damage by pathology according to the scintigraphic method and the radioclinical method
Tidsramme: 2 hours after injection
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The proportion of joints classified as pathological, according to the scintigraphic method and the radioclinical method
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2 hours after injection
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To quantitatively analyze the fixation of 99mTc-NTP 15-5 on the hand joints, in each pathology.
Tidsramme: 2 hours after injection
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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.
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2 hours after injection
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to evaluate the inter-observer reproducibility of visual and quantitative readings
Tidsramme: 2 hours after injection
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Inter-observer reproducibility measures: Cohen's kappa coefficient for visual readings (before to consensus) and intra-class correlation coefficient (ICC) for quantitative readings.
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2 hours after injection
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to describe the fixation of 99mTc-NTP 15-5 on skeletal joints other than hand joints, based on visual analysis.
Tidsramme: 2 hours after injection
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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.
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2 hours after injection
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to evaluate the tolerance of 99mTc-NTP 15-5.
Tidsramme: during 1 week after injection of 99mTc-NTP 15-5
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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.
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during 1 week after injection of 99mTc-NTP 15-5
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Marion CHANCHOU, Dr, Centre Jean Perrin
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
1. juli 2028
Studiet fullført (Antatt)
1. juli 2028
Datoer for studieregistrering
Først innsendt
29. mai 2026
Først innsendt som oppfylte QC-kriteriene
29. mai 2026
Først lagt ut (Faktiske)
3. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-523650-14-00
Plan for individuelle deltakerdata (IPD)
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