Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine (CARSPECT II)
8. juli 2026 opdateret af: 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
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Marion CHANCHOU, Dr
- Telefonnummer: 33473278089
- E-mail: marion.chachou@clermont.unicancer.fr
Studiesteder
-
-
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Clermont-Ferrand, Frankrig
- Chu Clermont Ferrand
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Kontakt:
- SYLVAIN MATHIEU
- Telefonnummer: MD
- E-mail: smathieu@chu-clermontferrand.fr
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-
PUY DE DOME
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Clermont-Ferrand, PUY DE DOME, Frankrig, 63011
- Centre Jean Perrin
-
Kontakt:
- MARION CHANCHOU, MD
- Telefonnummer: 04 73 27 82 01
- E-mail: Marion.chanchou@clermont.unicancer.fr
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Rheumatoid arthritis
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
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1 intravenøs injektion af 99mTc-NTP 15-5 ved en diagnostisk aktivitet på 15 MBq/kg (D0)
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|
Eksperimentel: digital osteoarthritis
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
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1 intravenøs injektion af 99mTc-NTP 15-5 ved en diagnostisk aktivitet på 15 MBq/kg (D0)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
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.
|
2 hour after injection
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
|
to evaluate the performance of 99mTc-NTP imaging 15-5 by joint group in each pathology.
Tidsramme: 2 hours after injection
|
Performance measures of 99mTc-NTP 15-5 imaging to detect an affected joint complex
|
2 hours after injection
|
|
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.
|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Marion CHANCHOU, Dr, Centre Jean Perrin
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. juli 2028
Studieafslutning (Anslået)
1. juli 2028
Datoer for studieregistrering
Først indsendt
29. maj 2026
Først indsendt, der opfyldte QC-kriterier
29. maj 2026
Først opslået (Faktiske)
3. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-523650-14-00
Plan for individuelle deltagerdata (IPD)
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