Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Jean Perrin
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov