Using 18F-fluciclovine PET/CT to detect multiple myeloma
A Phase II Trial Evaluating 18F-Fluciclovine PET/CT in Multiple Myeloma
This study is testing a new imaging method using a special tracer to see if it can better detect multiple myeloma in adults compared to the current method.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06103838 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the radiotracer 18F-fluciclovine in detecting multiple myeloma compared to the currently used 18F-FDG PET/CT. Participants, aged 18 and older with either newly diagnosed or relapsed multiple myeloma, will undergo imaging scans after receiving an injection of the radiotracer. The study will involve screening, blood tests, and three study visits to assess the concordance between the two imaging methods. The goal is to improve early detection of relapsed disease to enhance treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a documented diagnosis of multiple myeloma, either newly diagnosed or relapsed.
Not a fit: Patients with non-measurable disease or those who do not meet the inclusion criteria for multiple myeloma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of multiple myeloma relapses, allowing for timely and potentially more effective treatment options.
How similar studies have performed: While the use of 18F-fluciclovine has been established in prostate cancer, its application in multiple myeloma is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein \>= 3 g/dL and/or bone marrow plasma cells \>= 10% and at least one of the following: * Anemia: Hemoglobin \<=10 g/dL, or * Renal Failure: serum creatinine \>= 2.0 mg/dL, or * Hypercalcemia: Ca \>= 10.5 mg/dL, or * Lytic bone lesions on X-ray, CT, or PET/CT, or * \>= 2 focal lesions on spinal MRI, or * \>= 60% bone marrow plasma cells, or * Involved/un-involved serum free light chain ration \>= 100 * Participants must have measurable disease defined by any one of the following: * Monoclonal bone marrow plasma cells \> 5% * Serum monoclonal protein \>= 0.2 g/dl * Urine monoclonal protein \> 200 mg/24 hr * Serum immunoglobulin free light chain \> 10 mg/dL AND abnormal kappa/lambda ratio * A measurable lesion on PET/CT or MRI * Participants fit criteria for one of the following categories: * Newly diagnosed multiple myeloma (NDMM) * Relapsed and/or refractory multiple myeloma (RRMM) with at least 1 prior line of therapy * Age \>=18 years. * ECOG performance status \<= 2 * Negative serum or urine pregnancy test at screening for WOCBP. * Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) 24 hours prior to and for the 24 hours after each 18F-fluciclovine administration. * Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG * History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents. * Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them. * Uncontrolled intercurrent illness including, psychiatric illness/social situations that would limit compliance with study requirements. * Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with 18F-fluciclovine until 3 days after 18F-fluciclovine.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth M Hill, M.D. — National Cancer Institute (NCI)
- Study coordinator: NCI Medical Oncology Referral Office
- Email: ncimo_referrals@nih.gov
- Phone: (240) 760-6050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.