Digital Osteoarthritis or Rheumatoid ArthritisPhase 2CARSPECT IINCT07624994
Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine
A Phase 2 study testing 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg in people with Digital Osteoarthritis or Rheumatoid Arthritis, run by Centre Jean Perrin at 2 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digital Osteoarthritis or Rheumatoid Arthritis
- What is being tested?
- 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Oct 2026to 1 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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,
Who cannot join
- 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,
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Centre Jean Perrin
Clermont-Ferrand, PUY DE DOME, 63011
MARION CHANCHOU, MD, 04 73 27 82 01, Marion.chanchou@clermont.unicancer.fr
Chu Clermont Ferrand
Clermont-Ferrand
SYLVAIN MATHIEU, MD, smathieu@chu-clermontferrand.fr
About this study
Official title: 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
- Being tested
- 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
- Keywords
- proteoglycan tracer, cartilage
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kgDrug
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis | Experimental | 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg Receives: Drug: 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg |
| digital osteoarthritis | Experimental | 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg Receives: Drug: 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hour after injection
Secondary outcomes (7)
to evaluate the diagnostic performance of 99mTc-NTP 15-5 for differential diagnosis between DAO and RA.
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.
Measured: 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.
Performance measures of 99mTc-NTP 15-5 imaging to detect an affected joint complex
Measured: 2 hours after injection
to determine the prevalence of joint damage by pathology according to the scintigraphic method and the radioclinical method
The proportion of joints classified as pathological, according to the scintigraphic method and the radioclinical method
Measured: 2 hours after injection
To quantitatively analyze the fixation of 99mTc-NTP 15-5 on the hand joints, in each pathology.
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.
Measured: 2 hours after injection
to evaluate the inter-observer reproducibility of visual and quantitative readings
Inter-observer reproducibility measures: Cohen's kappa coefficient for visual readings (before to consensus) and intra-class correlation coefficient (ICC) for quantitative readings.
Measured: 2 hours after injection
to describe the fixation of 99mTc-NTP 15-5 on skeletal joints other than hand joints, based on visual analysis.
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.
Measured: 2 hours after injection
to evaluate the tolerance of 99mTc-NTP 15-5.
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.
Measured: during 1 week after injection of 99mTc-NTP 15-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Osteoarthritis or Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion CHANCHOU, Dr, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624994
- Sponsor's protocol ID
- 2025-523650-14-00
- Other IDs
- 2025
- Acronym
- CARSPECT II
- Status last verified
- Oct 2026
- First submitted
- 29 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine: Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07624994
- Acronym / sponsor ID
- CARSPECT II / 2025-523650-14-00
- Keywords
- proteoglycan tracer, cartilage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis | Experimental | Drug: 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg |
| digital osteoarthritis | Experimental | Drug: 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0) | Drug | Rheumatoid arthritis, digital osteoarthritis |
Primary outcome
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)
Time frame: 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.
7 secondary outcomes
to evaluate the diagnostic performance of 99mTc-NTP 15-5 for differential diagnosis between DAO and RA.
Time frame: 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.
Time frame: 2 hours after injection
to determine the prevalence of joint damage by pathology according to the scintigraphic method and the radioclinical method
Time frame: 2 hours after injection
To quantitatively analyze the fixation of 99mTc-NTP 15-5 on the hand joints, in each pathology.
Time frame: 2 hours after injection
to evaluate the inter-observer reproducibility of visual and quantitative readings
Time frame: 2 hours after injection
to describe the fixation of 99mTc-NTP 15-5 on skeletal joints other than hand joints, based on visual analysis.
Time frame: 2 hours after injection
to evaluate the tolerance of 99mTc-NTP 15-5.
Time frame: during 1 week after injection of 99mTc-NTP 15-5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marion CHANCHOU, Dr principal investigator
Centre Jean Perrin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg in people with Digital Osteoarthritis or Rheumatoid Arthritis, run by Centre Jean Perrin at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion CHANCHOU, Dr (33473278089, marion.chachou@clermont.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 2 hour after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.