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

Not Yet RecruitingPhase 2

Sponsor: Centre Jean Perrin

Conditions: Digital Osteoarthritis or Rheumatoid Arthritis

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

Countries: France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (2)

Clermont-Ferrand, PUY DE DOME, France
Clermont-Ferrand, France