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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Drug1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Rheumatoid arthritisExperimental treatment 1 intervention
Group B: digital osteoarthritisExperimental treatment 1 intervention
Trial outcomes
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)
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.
Time frame
2 hour after injectionSecondary outcomes
1
to evaluate the diagnostic performance of 99mTc-NTP 15-5 for differential diagnosis between DAO and RA.
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.
Time frame
2 hours after injection of 99mTc-NTP 15-52
to evaluate the performance of 99mTc-NTP imaging 15-5 by joint group in each pathology.
Performance measures of 99mTc-NTP 15-5 imaging to detect an affected joint complex
Time frame
2 hours after injection3
to determine the prevalence of joint damage by pathology according to the scintigraphic method and the radioclinical method
The proportion of joints classified as pathological, according to the scintigraphic method and the radioclinical method
Time frame
2 hours after injection4
To quantitatively analyze the fixation of 99mTc-NTP 15-5 on the hand joints, in each pathology.
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.
Time frame
2 hours after injectionSponsors and contacts
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Source ClinicalTrials.gov
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