Actively Recruiting
18F-Fluciclovine PET/CT in Multiple Myeloma
Led by National Cancer Institute (NCI) · Updated on 2026-05-07
60
Participants Needed
1
Research Sites
401 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
18F-Fluciclovine PET/CT in Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a documented diagnosis of multiple myeloma defined by IMWG criteria
- Newly diagnosed multiple myeloma (NDMM) or relapsed/refractory multiple myeloma (RRMM) with at least one prior treatment
- Age 18 years or older
- ECOG performance status of 0 to 2
- Measurable disease by specific blood, urine, or imaging criteria
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception around 18F-fluciclovine administration
- Ability and willingness to provide informed consent
You will not qualify if you...
- History of allergic reactions to compounds similar to 18F-FDG or 18F-fluciclovine
- Severe claustrophobia not responsive or unwilling to take oral anxiety medication
- Uncontrolled illnesses or psychiatric/social conditions limiting study compliance
- Breastfeeding mothers must stop breastfeeding until 3 days after 18F-fluciclovine treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI Medical Oncology Referral Office
CONTACT
E
Elizabeth M Hill, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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