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18F-Fluciclovine PET/CT in Multiple Myeloma

StatusRecruiting
PhasePhase 2
Started2024-03-25
View on ClinicalTrials.gov ↗
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....

Amendment history 2 changes detected by DataLookout

2026-07-01
critical
Primary completion pushed: 2026-12-06 → 2027-12-06
2026-07-01
minor
Completion pushed: 2031-12-06 → 2032-12-06
Trial Details
NCT Number NCT06103838
Lead Sponsor National Cancer Institute (NCI)
Conditions Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Relapsed and/or Refractory Multiple Myeloma (RRMM)
Enrollment 60 participants
Start Date 2024-03-25
Primary Completion 2027-12-06 (estimated)
Study Completion 2032-12-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-01