NCT06103838 · National Cancer Institute (NCI)
18F-Fluciclovine PET/CT in Multiple Myeloma
What this study is about
Background: Multiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier.
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Background: Multiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier. Objective: To find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose. Eligibility: Adults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM). Design: Participants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET/CT scan takes images of their body. All participants will have 3 study visits. During each visit they will have: Two PET/CT scans. One with 18F-FDG, one with 18F-fluciclovine. An optional magnetic resonance imaging scan. A bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone. These tests may be spread over 30 days for each visit. NDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first. All participants will have a third study visit after 5 years or when their disease progresses.
Interventions
DRUG
18F-fluciclovine injection
370 MBq (10 mCi)(+/-20%) as a bolus intravenous injection.
PROCEDURE
18F-FDG PET/CT
All participants will undergo 18F-FDG PET/CT within 30 days of the 18F-fluciclovine PET/CT scan
Primary outcome measures
To determine the concordance between 18F-fluciclovine PET/CT and 18F-FDG PET/CT in participants with multiple myeloma.
Time frame: After 50 evaluable participants have completed baseline scans.
The performance of 18F-fluciclovine PET/CT is assessed by concordance with the 18F-FDG PET/CT imaging in scan positivity. A positive lesion is defined as focal uptake greater than background associated with abnormal CT findings (i.e., lytic bone lesions or extramedullary tissue.) The point estimates and 95% confidence intervals of the concordance rate in scan positivity between 18F-fluciclovine and 18F-FDG PET/CT will be reported.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein \>= 3 g/dL and/or bone marrow plasma cells \>= 10% and at least one of the following:
- Anemia: Hemoglobin \<=10 g/dL, or
- Renal Failure: serum creatinine \>= 2.0 mg/dL, or
- Hypercalcemia: Ca \>= 10.5 mg/dL, or
- Lytic bone lesions on X-ray, CT, or PET/CT, or
- \>= 2 focal lesions on spinal MRI, or
- \>= 60% bone marrow plasma cells, or
- Involved/un-involved serum free light chain ration \>= 100
- Participants must have measurable disease defined by any one of the following:
- Monoclonal bone marrow plasma cells \> 5%
- Serum monoclonal protein \>= 0.2 g/dl
- Urine monoclonal protein \> 200 mg/24 hr
- Serum immunoglobulin free light chain \> 10 mg/dL AND abnormal kappa/lambda ratio
- A measurable lesion on PET/CT or MRI
- Participants fit criteria for one of the following categories:
- Newly diagnosed multiple myeloma (NDMM)
- Relapsed and/or refractory multiple myeloma (RRMM) with at least 1 prior line of therapy
- Age \>=18 years.
- ECOG performance status \<= 2
- Negative serum or urine pregnancy test at screening for WOCBP.
- Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) 24 hours prior to and for the 24 hours after each 18F-fluciclovine administration.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.
- Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.
- Uncontrolled intercurrent illness including, psychiatric illness/social situations that would limit compliance with study requirements.
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with 18F-fluciclovine until 3 days after 18F-fluciclovine.
Where
- Bethesda, Maryland
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations