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Phase II Study of 99mTc NTP15-5 Imaging to Detect Hand Joint Disease in Patients with Rheumatoid Arthritis and Finger Osteoarthritis

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at two common hand conditions that cause pain and loss of movement: rheumatoid arthritis, an autoimmune disease that inflames joints, and digital osteoarthritis, a wear‑and‑tear arthritis that affects the finger joints. A new imaging agent called 99mTc NTP15-5 will be used to help doctors see which joints are diseased. The agent is given by a small intravenous infusion, which means it is injected into a vein, and then special pictures of the hands are taken.

The purpose of the study is to find out how well this agent can identify abnormal hand joints in each condition. After the infusion, participants will have a short imaging session where a camera detects the agent inside the joints, creating what is known as scintigraphic imaging. The resulting images are reviewed by experts who do not know the participant’s diagnosis, so the assessment is unbiased. The whole process usually involves one visit for the injection and imaging, followed by a brief check‑in to record any side effects within the next week.

In this context, nuclear medicine refers to a medical field that uses tiny amounts of radioactive material to create pictures of how organs and tissues are working. The “tracer” in the agent lights up areas where the joints are inflamed, making them visible on the images. Safety is closely monitored, and any discomfort or reaction after the infusion is recorded and evaluated by the study team.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
After joining the study, you sign an informed consent form that explains the purpose of the trial and the procedures that will be performed.
Baseline clinical information, such as medical history and current medications, is recorded.
Step 2
Baseline clinical assessment
A health professional conducts a physical examination of the hands and may obtain standard radiographic images to document the current condition of the joints.
Step 3
Preparation for tracer injection
You are instructed to remain comfortably seated or lying down while the study staff prepares the radioactive tracer.
The tracer used in this trial is 99mTc-ntp15-5, which contains a compound called triethyl‑[3‑(1,4,7,10,13‑pentazacyclopentadec‑1‑yl)propyl]azanium chloride.
Step 4
Tracer administration
A single dose of 99mTc-ntp15-5 is given by intravenous infusion.
The dose is calculated as 15 mbq/kg (15 megabecquerel per kilogram of body weight), which is injected once.
Step 5
Hand imaging (scintigraphy)
Shortly after the injection, you undergo functional imaging of both hands.
The imaging device records the distribution of the tracer in each of the 15 joints of the hands to identify abnormal uptake patterns.
Step 6
Post‑imaging observation
After the scan, you are observed for a short period to ensure that no immediate reaction occurs.
If no reaction is seen, you may leave the imaging facility.
Step 7
Safety follow‑up
Within one week after the injection, you return for a follow‑up visit or are contacted to report any side effects.
Adverse events are recorded using a standard grading system (nci‑ctcae v5.0).
Step 8
Final study visit
A final clinical evaluation may be performed to complete the study records.
The results of the imaging are compared with the baseline radiographic and clinical information to determine the diagnostic accuracy of the tracer.

Who can join the trial?

11 criteria

Karnofsky Index greater than 70%, meaning you are able to carry out most daily activities without major help.
Stop taking NSAIDs (common pain‑relieving medicines such as ibuprofen or naproxen) for at least 8 days before the study.
Provide a written, signed and dated informed consent form agreeing to take part.
Be covered by a health‑insurance plan.
If you are a woman who could become pregnant, have a negative serum pregnancy test performed within 7 days before the study injection.
Be able and willing to attend clinic visits, undergo the required tests, and follow the study procedures.
For the rheumatoid arthritis group: have a confirmed diagnosis of rheumatoid arthritis that is less than 5 years old, according to the ACR/EULAR criteria (standard guidelines used by doctors to diagnose this condition).
For the rheumatoid arthritis group: experience finger pain rated higher than 4 on a 0‑to‑10 pain scale.
For the rheumatoid arthritis group: have active synovitis (inflammation of the joint lining) that can be seen on a clinical exam and confirmed with ultrasound imaging.
For the digital osteoarthritis group: have a confirmed diagnosis of symptomatic digital osteoarthritis (joint wear in the fingers) that is less than 5 years old, with finger pain rated higher than 4 on a 0‑to‑10 pain scale.
Be within the age range allowed by the study (as defined by the trial’s inclusion parameters).

Who cannot join the trial?

12 criteria

Using pain relievers called NSAIDs (such as ibuprofen) at the time of the study
Cannot attend the required medical follow‑up visits because of distance, family, social, or mental reasons
For rheumatoid arthritis patients only: currently taking biologic medicines (also called biotherapies) such as anti‑TNF alpha, rituximab, abatacept, anti‑IL6, or anti‑JAK drugs
For rheumatoid arthritis patients only: having a previous hand condition referred to as hand AD
Having received a local injection of corticosteroid into a hand joint within the past month
Having any past surgery on the bones or joints of the hands (ostearticular surgery)
Having any soft tissue surgery (such as tendon or skin surgery) on the hands within the last six months
Being younger than 18 years old
Being pregnant or breastfeeding
Having a body weight index (BMI) higher than 30, which indicates obesity
Having a known allergy to any ingredient (called excipients) in the 99mTc‑NTP 15‑5 solution
Being under legal protection such as imprisonment, guardianship, curatorship, or judicial protection that prevents giving free consent

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Verified sites

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Centre Jean Perrin
Verified
Clermont Ferrand, France
University Hospital Of Clermont-Ferrand
Verified
Clermont Ferrand, France

Trial locations

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Investigated drugs

99mTc NTP15-5 is a special imaging agent used in nuclear medicine. It contains a very small amount of a radioactive material called technetium‑99m. When it is given by an IV (a needle placed in a vein), it travels through the blood and gathers in the hand joints. A special camera can then detect the tiny radiation and create pictures that show how each joint is functioning. In this trial, the agent is being tested to see if it can clearly show which hand joints are affected by digital osteoarthritis or rheumatoid arthritis.

What is already known about the treatment

99mTc NTP15-5 - 99mTc NTP15-5 is administered by intravenous infusion, typically at a dose of 15 MBq per kilogram of body weight. It is an investigational radiopharmaceutical currently being studied in a phase II trial and is not yet approved for general clinical use. The agent is used to image hand joints affected by rheumatoid arthritis or digital osteoarthritis, helping doctors locate the diseased areas. It contains the radioactive element technetium‑99m, which emits gamma rays that are detected by a nuclear imaging camera, and it belongs to the class of diagnostic radiopharmaceuticals.

Investigated diseases

Rheumatoid arthritis
It is an autoimmune disease that causes inflammation in the lining of joints, especially in the hands. The inflammation leads to swelling, warmth, and stiffness that can last for many hours. Over time, the joint lining thickens and can damage the cartilage and bone, making the joint less flexible. The disease often starts in the small joints of the fingers and spreads to other joints. Joint changes develop gradually, with periods of more intense symptoms followed by quieter times.
Digital osteoarthritis
It is a wear‑and‑tear condition that affects the joints at the ends of the fingers. The cartilage that cushions the joint slowly breaks down, causing the bones to rub together. This results in pain, stiffness, and sometimes small bony growths that can be felt under the skin. The condition usually progresses slowly, with symptoms worsening as the joint surface becomes more uneven. Over the years the joint may lose motion and become less smooth.