Starting soon
Phase 2
Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine
Condition(s) studied
Digital Osteoarthritis or Rheumatoid Arthritis
Investigational drug(s) / intervention(s)
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
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)
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
Eligibility
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
Primary outcome measure(s)
- 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) — 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.
Trial sites (2)
| Facility | City | Region | Status |
| Centre Jean Perrin |
Clermont-Ferrand |
PUY DE DOME |
|
| Chu Clermont Ferrand |
Clermont-Ferrand |
France |
|
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