2025-523650-14-00Not yet recruitingPhase 2

functional imaging of digital osteoarthritis and rheumatoid arthritis using 99mTc-NTP15-5 in nuclear medicine : phase II clinical study

Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 Jul 2026

Brief summary (registry, in English)

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)

Status (registry): Not yet recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 80 (estimated)
First submitted: 21 Apr 2026
Start date: 1 May 2026
Lead sponsor: Centre Jean Perrin
Diseases: Rheumatoid arthritis
EU CT number: 2025-523650-14-00

What you commit to

Study type: Interventional · Phase 2
Planned participants: 80
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with hand osteoarthritis of the fingers or with rheumatoid arthritis, diagnosed less than 5 years ago, who have finger pain and no anti-inflammatory pills (NSAIDs) in use.

Age: 18 years or older
Sex: All sexes
Disease stage: Finger osteoarthritis (DOA) with symptoms, diagnosed less than 5 years ago, finger pain above 4 out of 10. Or rheumatoid arthritis diagnosed less than 5 years ago, with finger pain above 4 out of 10 and active joint inflammation (synovitis) seen clinically and on ultrasound.
Earlier treatment: People with osteoarthritis must stop NSAIDs for at least 8 days. People with rheumatoid arthritis cannot be on biotherapies (anti-TNF alpha, rituximab, abatacept, anti-IL6, anti-JAK). No corticosteroid injection into a hand joint in the month before the 99mTc-NTP 15-5 injection.
Biomarker or test result: Rheumatoid arthritis must be certain by the ACR/EULAR criteria. Karnofsky Index above 70%. Women who can have children need a negative pregnancy blood test within 7 days before the injection.

Main reasons for not taking part

Ongoing use of NSAIDs
Pregnant or breastfeeding
BMI above 30
Past surgery on the hand bones or joints, or soft tissue surgery on the hands in the last 6 months
Known allergy to an ingredient of the 99mTc-NTP 15-5 solution

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

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

Age

Both groups : Patients under the age of 18 years old

Other

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

Who the study is looking for

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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
University Hospital Of Clermont-Ferrand	Clermont-Ferrand	France	Not yet recruiting
Centre Jean Perrin	Clermont-Ferrand	France	Not yet recruiting

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