18F-Fluciclovine PET/CT in Multiple Myeloma

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06103838
Phase
PHASE2
Status
Recruiting
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Conditions

  • Multiple Myeloma
  • Newly Diagnosed Multiple Myeloma (NDMM)
  • Relapsed and/or Refractory Multiple Myeloma (RRMM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • 18F-fluciclovine injection — DRUG
    370 MBq (10 mCi)(+/-20%) as a bolus intravenous injection.
  • 18F-FDG PET/CT — PROCEDURE
    All participants will undergo 18F-FDG PET/CT within 30 days of the 18F-fluciclovine PET/CT scan

Study Details

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.

Key Dates

Start date
Mar 25, 2024
Status verified
Feb 2026
Primary completion
Dec 6, 2026
Completion
Dec 6, 2031

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 18F-fluciclovine PET/CT in Multiple Myeloma
    Evaluate 18F-fluciclovine PET/CT in participants with multiple myeloma at Timepoint #1, Timepoint #2 ( after induction treatment (NDMM) or six months (RRMM)) and at Timepoint #3 (the time of progression or 5 years).

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NCI Medical Oncology Referral Office
[email protected]
240-760-6050

Find similar trials in Bethesda, MD

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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