Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine
CARSPECT II
1 other identifier
interventional
80
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2026
CompletedFirst Posted
Study publicly available on registry
June 3, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
July 10, 2026
July 1, 2026
1.9 years
May 29, 2026
July 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
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
Secondary Outcomes (7)
to evaluate the diagnostic performance of 99mTc-NTP 15-5 for differential diagnosis between DAO and RA.
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.
2 hours after injection
to determine the prevalence of joint damage by pathology according to the scintigraphic method and the radioclinical method
2 hours after injection
To quantitatively analyze the fixation of 99mTc-NTP 15-5 on the hand joints, in each pathology.
2 hours after injection
to evaluate the inter-observer reproducibility of visual and quantitative readings
2 hours after injection
- +2 more secondary outcomes
Study Arms (2)
Rheumatoid arthritis
EXPERIMENTAL99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
digital osteoarthritis
EXPERIMENTAL99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Interventions
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre Jean Perrin
Clermont-Ferrand, PUY DE DOME, 63011, France
Chu Clermont Ferrand
Clermont-Ferrand, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marion CHANCHOU, Dr
Centre Jean Perrin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2026
First Posted
June 3, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
July 10, 2026
Record last verified: 2026-07