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ClinicalTrials.gov ID

NCT07624994

Lead Sponsor

Centre Jean PerrinOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

80Estimated

Last Update Posted

Jul 10, 2026Actual

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Jul 1, 2028Estimated

Completion Date

Jul 1, 2028Estimated

Official Title

Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine: Phase II Clinical Study

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

• Digital Osteoarthritis or Rheumatoid Arthritis

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Diagnostic

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Centre Jean PerrinOTHER

smathieu@chu-clermontferrand.frMD