RecruitingRare disease

Study on Imaging Multiple Myeloma Patients Using Fluciclovine (18F) PET/CT

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The study will use a special imaging technique called Fluciclovine PET/CT to help detect the disease. Fluciclovine is a substance that is injected into the body and helps to highlight areas of cancer when used with PET/CT scans. The purpose of the study is to see how well Fluciclovine PET/CT can identify patients with multiple myeloma compared to another imaging method called FDG PET/CT.

Participants in the study will undergo imaging with Fluciclovine PET/CT and FDG PET/CT. The study aims to find out how many patients show positive results with Fluciclovine PET/CT but negative results with FDG PET/CT, and how these results relate to the patients' progression-free survival (PFS) and overall survival (OS). The study will also look at the safety of using Fluciclovine by monitoring any side effects that occur.

The trial will compare the results of the two imaging methods to see how well they agree with each other. This information will help researchers understand the effectiveness of Fluciclovine PET/CT in detecting multiple myeloma and its potential benefits for patients. The study is expected to continue until the end of 2026.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment in the study
Participation begins after enrollment in the REMNANT study Part 2. Eligibility for FDG PET/CT is required.
Step 2
Preparation for imaging
Preparation involves understanding the imaging process using Fluciclovine PET/CT. This imaging technique is used to detect certain conditions in multiple myeloma patients.
Step 3
Administration of fluciclovine
Fluciclovine is administered as an injection. The product used is Axumin, which is a solution for injection with a concentration of 1,600 MBq/mL.
Step 4
Imaging procedure
After the injection, a PET/CT scan is performed. This scan helps in detecting the presence of multiple myeloma by comparing results with FDG PET/CT.
Step 5
Evaluation of results
The results are evaluated to determine the number of patients with positive Fluciclovine PET/CT and negative FDG PET/CT. This evaluation helps in understanding progression-free survival (PFS) and overall survival (OS).
Step 6
Safety assessment
The safety of Fluciclovine is assessed by monitoring any adverse events (AEs) that occur during the study.
Step 7
Comparison of imaging techniques
The study also involves comparing the results of Fluciclovine PET/CT with FDG PET/CT to determine the agreement between these assessments.

Who can join the trial?

5 criteria

Patients must have a condition called multiple myeloma.
Patients need to be part of the REMNANT study, specifically in Part 2.
Patients should be eligible for a test called FDG PET/CT, which is a type of imaging scan used to look at the body's tissues.
Both men and women can participate in the study.
The study does not include people who are considered a vulnerable population, meaning those who might need special protection or care.

Who cannot join the trial?

3 criteria

Patients who do not give their informed consent, which means they do not agree to take part in the study or do not agree to the rules of the study location.
Patients who have a hypersensitivity, which is an allergic reaction, to the medicine being studied or to any of the excipients, which are the inactive ingredients used to make the medicine.
Patients with renal impairment, which means they have problems with how their kidneys work, especially if the extra radiation exposure (the energy used during medical imaging) might cause too much risk.

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Verified sites

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Oslo Universitetssykehus HF
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Oslo, Norway

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Investigated drugs

Fluciclovine
is a special imaging agent used in PET/CT scans. It helps doctors see certain types of cancer cells more clearly. In this study, it is used to find cancer in patients with multiple myeloma, a type of blood cancer. The goal is to see if Fluciclovine can detect cancer cells that other imaging methods might miss.
FDG
is another imaging agent used in PET/CT scans. It is commonly used to find cancer cells because they often use more sugar than normal cells, and FDG is a sugar-like substance. In this study, FDG is used to compare its effectiveness with Fluciclovine in detecting cancer in multiple myeloma patients.

Fluciclovine (18F)

What is already known about the treatment

Fluciclovine – Fluciclovine is administered as an injection for use in PET/CT imaging. It is currently being studied in clinical trials for its effectiveness in detecting multiple myeloma, particularly in patients who may not show positive results with traditional FDG PET/CT scans. The main therapeutic indication for Fluciclovine is to improve the detection of cancerous lesions in multiple myeloma. At the molecular level, Fluciclovine works by mimicking amino acids, which are taken up by cancer cells at a higher rate, allowing for better imaging contrast. It is classified as a radiopharmaceutical agent used in diagnostic imaging.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. These cells become abnormal and multiply uncontrollably, leading to the production of abnormal proteins that can cause damage to bones and other organs. As the disease progresses, it can lead to bone pain, fractures, and anemia due to the overcrowding of healthy blood cells. Patients may also experience kidney problems and increased susceptibility to infections. The disease often progresses slowly, but it can become more aggressive over time.