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Not yet recruitingNCT07624994CARSPECT IIUpdated Oct 20, 2026

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

A Phase 2 interventional study of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg in Digital Osteoarthritis or Rheumatoid Arthritis, sponsored by Centre Jean Perrin. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Centre Jean Perrin · Phase 2, Interventional, and Diagnostic

Updated Oct 20, 2026Start date movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 357 studies in Arthritis, Rheumatoid with a site in France — 42 open to participants now, 62 under way, 6 of them phase 3. Arthritis, Rheumatoid · France.

Planned enrollment
152nd of 222
80 · median 167
Started
2026
with 8 others
Phase 2
33 of 357
4 open now
Primary completion
2028-07
later than 41 of 61 live
Registered
355th of 357
by date

Among the 357 studies in Arthritis, Rheumatoid with a site in France, this one is the 152nd largest by planned enrollment of the 222 interventional ones that give a count, is one of 9 that started in 2026, is one of 33 in phase 2, reaches primary completion later than 41 of the 61 other live ones, and was the 355th registered.

Arthritis, Rheumatoid

3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.

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Open to participants now

42 of the 357 studies in Arthritis, Rheumatoid with a site in France are open now. Recruiting first, the newest first:

37 more — sign in →

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A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

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

03

Conditions studied

  • Digital Osteoarthritis or Rheumatoid Arthritis

Keywords

  • proteoglycan tracer
  • cartilage
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • index > 70%
  • Obtaining written, signed and dated
  • Affiliation to a health insurance plan
  • For women of childbearing age (fertile, after menarche and until 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

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 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Rheumatoid arthritis

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

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

  • Experimental
    digital osteoarthritis

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

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

Interventions

  • Drug99mTc-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)

06

What researchers measure

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.

    Time frame: 2 hour after injection

Secondary outcomes

  1. 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.

    Time frame: 2 hours after injection of 99mTc-NTP 15-5

  2. 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

    Time frame: 2 hours after injection

  3. 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

    Time frame: 2 hours after injection

  4. 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.

    Time frame: 2 hours after injection

  5. 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.

    Time frame: 2 hours after injection

  6. 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.

    Time frame: 2 hours after injection

  7. 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.

    Time frame: during 1 week after injection of 99mTc-NTP 15-5

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jul 2028, 21 months later.

Of 42 non-industry phase 2 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 49. This study's planned 21 months is below that.

Counting every sponsor, half of 158 studies reached it within 18 months; a quarter within 13 and three quarters within 30.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 20, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2026
First posted
Jun 3, 2026
StartEst.
Oct 1, 2026was Aug 2026
Primary completionEst.
Jul 1, 2028
CompletionEst.
Jul 1, 2028
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Aug 1, 2026→Oct 1, 2026
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Start date Aug 1, 2026→Oct 1, 2026
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07624994
Lead sponsor
Centre Jean Perrin
Responsible party
Sponsor
First posted
Jun 3, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Jul 1, 2028 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Marion CHANCHOU, Dr
Contact
marion.chachou@clermont.unicancer.fr
33473278089
Marion CHANCHOU, Dr
principal investigator · Centre Jean Perrin

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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