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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Digital Osteoarthritis or Rheumatoid Arthritis
• Intervention / Treatment: Drug: 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marion CHANCHOU, Dr; Phone Number: 33473278089; Email: marion.chachou@clermont.unicancer.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Chu Clermont Ferrand
    • Contact: SYLVAIN MATHIEU; Phone Number: MD; Email: smathieu@chu-clermontferrand.fr
  • PUY DE DOME
    • Clermont-Ferrand, PUY DE DOME, France, 63011
      • Centre Jean Perrin
      • Contact: MARION CHANCHOU, MD; Phone Number: 04 73 27 82 01; Email: Marion.chanchou@clermont.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rheumatoid arthritis; 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg	Drug: 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg; 1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)
Experimental: digital osteoarthritis; 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg	Drug: 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg; 1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hour after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours after injection of 99mTc-NTP 15-5
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	2 hours after injection
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	2 hours after injection
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.	2 hours after injection
to evaluate the inter-observer reproducibility of visual and quantitative readings	Inter-observer reproducibility measures: Cohen's kappa coefficient for visual readings (before to consensus) and intra-class correlation coefficient (ICC) for quantitative readings.	2 hours after injection
to describe the fixation of 99mTc-NTP 15-5 on skeletal joints other than hand joints, based on visual analysis.	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.	2 hours after injection
to evaluate the tolerance 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.	during 1 week after injection of 99mTc-NTP 15-5

Collaborators and Investigators

• Sponsor: Centre Jean Perrin
• Investigators: Principal Investigator: Marion CHANCHOU, Dr, Centre Jean Perrin

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: cartilage; proteoglycan tracer
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid
• Other Study ID Numbers: 2025-523650-14-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No