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18F-Fluciclovine PET/CT in Multiple Myeloma

NCT06103838 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-22

No results posted yet for this 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

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

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Elizabeth M Hill, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2026-12-06
Completion
2031-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06103838 on ClinicalTrials.gov