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18F-Fluciclovine PET/CT in Multiple Myeloma
NCT06103838 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG 18F-fluciclovine injection
- PROCEDURE 18F-FDG PET/CT
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-03-25 |
| Est. Completion | 2031-12-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06103838
The ClinicalTrials.gov registry entry for NCT06103838 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions — of which 18F-fluciclovine injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06103838 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06103838 about?
NCT06103838 is a clinical study titled "18F-Fluciclovine PET/CT in Multiple Myeloma". 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 rad...
What is the current status of trial NCT06103838?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-03-25. Estimated completion is 2031-12-06.
What conditions does trial NCT06103838 study?
This clinical trial studies the following conditions: Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Relapsed and/or Refractory Multiple Myeloma (RRMM). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06103838?
The interventions under investigation include: 18F-fluciclovine injection (DRUG), 18F-FDG PET/CT (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06103838?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06103838 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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