Digital Osteoarthritis or Rheumatoid Arthritis
Conditions
Keywords
proteoglycan tracer, cartilage
Brief 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
Interventions
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)
Sponsors
Centre Jean Perrin
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to evaluate the diagnostic performance of 99mTc-NTP 15-5 for differential diagnosis between DAO and RA. | 2 hours after injection of 99mTc-NTP 15-5 | 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. |
| to evaluate the performance of 99mTc-NTP imaging 15-5 by joint group in each pathology. | 2 hours after injection | Performance measures of 99mTc-NTP 15-5 imaging to detect an affected joint complex |
| to determine the prevalence of joint damage by pathology according to the scintigraphic method and the radioclinical method | 2 hours after injection | The proportion of joints classified as pathological, according to the scintigraphic method and the radioclinical method |
| To quantitatively analyze the fixation of 99mTc-NTP 15-5 on the hand joints, in each pathology. | 2 hours after injection | 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. |
| to evaluate the inter-observer reproducibility of visual and quantitative readings | 2 hours after injection | Inter-observer reproducibility measures: Cohen's kappa coefficient for visual readings (before to consensus) and intra-class correlation coefficient (ICC) for quantitative readings. |
| to describe the fixation of 99mTc-NTP 15-5 on skeletal joints other than hand joints, based on visual analysis. | 2 hours after injection | All skeletal joints other than the hands will be rated by a score : 0: no fixation, 1: fixation \< adjacent diaphysis, 2: fixation = adjacent diaphysis, 3: fixation \> adjacent diaphysis. |
| to evaluate the tolerance of 99mTc-NTP 15-5. | during 1 week after injection of 99mTc-NTP 15-5 | Adverse events (AEs) assessed according to the NCI-CTCAE V5.0 criteria and associated with 99mTc-NTP 15-5 occurring within the week following the injection. |
Countries
France
Contacts
CONTACTMarion CHANCHOU, Dr
PRINCIPAL_INVESTIGATORMarion CHANCHOU, Dr
Centre Jean Perrin
Outcome results
None listed