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

Phase II Interventional Digital Osteoarthritis or Rheumatoid Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg.
Who it may be relevant to
Registry conditions: Digital Osteoarthritis or Rheumatoid Arthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Drug 99mTc-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)

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 2 centers
  • Centre Jean Perrin — Clermont-Ferrand
  • Chu Clermont Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT07624994 · 2025-523650-14-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗