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Not yet recruitingNCT07624994CARSPECT IIUpdated Jul 10, 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 2026-07-10.

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

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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

02

Conditions studied

  • Digital Osteoarthritis or Rheumatoid Arthritis

Keywords

  • proteoglycan tracer
  • cartilage
03

Who can participate

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

Inclusion criteria

  • 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,

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 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
04

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)

05

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

06

Study locations

2 sites
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07624994
Lead sponsor
Centre Jean Perrin
Responsible party
Sponsor
First posted
Jun 3, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Jul 1, 2028 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Jul 10, 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 ↗

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