functional imaging of digital osteoarthritis and rheumatoid arthritis using 99mTc-NTP15-5 in nuclear medicine : phase II clinical study
Key facts
- Where
- Clermont-Ferrand, FranciaországSee the 2 sites
- Phase
- 2. fázis
Where in Franciaország
- Centre Jean PerrinClermont-Ferrand, FranciaországToborzás még nem indult
- University Hospital Of Clermont-FerrandClermont-Ferrand, FranciaországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Jean Perrin
- Trial code
- EU 2025-523650-14-00
- Record updated
- 2026. július 24.
- Original description
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)Read full original descriptionShow less
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)
Inclusion: Both Groups : Karnofsky Index > 70%; DOA Group : stopping NSAIDs for at least 8 days; Both groups: Obtaining written, signed and dated informed consent; Both groups: Affiliation to a health insurance plan; Both groups : For women of childbearing age (fertile, after menarche and until postmenopausal unless sterile after surgery) including on a GnRH agonist for ovarian suppression: serum pregnancy test negative at baseline (within 7 days prior to injection of 99mTc-NTP 15-5). Menopause is defined as amenorrhea for at least 12 consecutive months without any other cause and FSH and oestradiol levels consistent with those of the post-menopausal period; Both groups : Ability and willingness to comply with clinic visits, tests, and the protocol; RA Group : certain diagnosis of rheumatoid arthritis less than 5 years old, according to the ACR/EULAR criteria; RA Group : symptomatic (finger pain > 4 /10 on a numerical scale); RA Group :active synovitis (clinical and ultrasound); DOA Group : certain diagnosis of symptomatic DOA less than 5 years old (finger pain > 4 /10 on a numerical scale).
Exclusion: Both groups : Inability to undergo the trial’s medical follow-up due to geographical, family, social, or psychological reasons. These conditions must be discussed with the patient prior to enrollment in the study; Both groups : Treatment by local joint corticosteroid infiltration at the hand level in the month preceding the administration of 99mTc-NTP 15-5; RA Group : Patients with a history of hand AD; Both groups : History of osteoarticular surgery on the hands; Both groups : History of soft tissue surgery on the hands within the past 6 months; Both groups : History of known allergy to the excipients contained in the 99mTc-NTP 15-5 solution; Both groups : Patients under the age of 18 years old; Both Groups : Ongoing NSAID usage; RA Group : Use of biotherapies (anti-TNF alpha, rituximab, abatacept, anti-IL6 and anti-JAK) as background treatment; Both groups : Pregnant or breastfeeding patients; Both groups : BMI > 30; Both groups : Individuals deprived of their liberty, under guardianship/curatorship, or subject to judicial protection.