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Starting soon Phase 2

Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine

NCT07624994 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2026-10-01
Last updated
2026-10-20

Condition(s) studied

Digital Osteoarthritis or Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg

99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg: 1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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) — 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.

Trial sites (2)

FacilityCityRegionStatus
Centre Jean Perrin Clermont-Ferrand PUY DE DOME
Chu Clermont Ferrand Clermont-Ferrand France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07624994 on ClinicalTrials.gov ↗ ← All trials in France