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NCT Number: NCT07624994

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Jean Perrin, Clermont-Ferrand, PUY DE DOME, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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

Drug

1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)

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)

    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.

Secondary outcomes

  1. 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

    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.

  2. to evaluate the performance of 99mTc-NTP imaging 15-5 by joint group in each pathology.

    Time frame: 2 hours after injection

    Performance measures of 99mTc-NTP 15-5 imaging to detect an affected joint complex

  3. to determine the prevalence of joint damage by pathology according to the scintigraphic method and the radioclinical method

    Time frame: 2 hours after injection

    The proportion of joints classified as pathological, according to the scintigraphic method and the radioclinical method

  4. To quantitatively analyze the fixation of 99mTc-NTP 15-5 on the hand joints, in each pathology.

    Time frame: 2 hours after injection

    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.

  5. to evaluate the inter-observer reproducibility of visual and quantitative readings

    Time frame: 2 hours after injection

    Inter-observer reproducibility measures: Cohen's kappa coefficient for visual readings (before to consensus) and intra-class correlation coefficient (ICC) for quantitative readings.

  6. 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

    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.

  7. to evaluate the tolerance of 99mTc-NTP 15-5.

    Time frame: during 1 week after injection 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marion CHANCHOU, Dr

CONTACT

[email protected]

33473278089

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine: Phase II Clinical Study

Acronym: CARSPECT II

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 3, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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