Clinical trial · Interventional
Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography
A Pilot Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]Florbetaben Positron Emission Tomography for Detecting Amyloidosis in Multiple Myeloma Patients
NCT03779815CI-TRIAL-00038232PETcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
\[18F\]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]Florbetaben | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]Florbetaben PET/CT imaging
- description
- * Maximally 18 subjects with multiple myeloma (up to 6 subjects in whom amyloidosis in suspected and up to 12 subjects in whom amyloidosis is not suspected) * Intravenous injection of \[18F\]Florbetaben and PET/CT scanning * Intervention: Drug (\[18F\]Florbetaben)
- interventionNames
- Drug: [18F]Florbetaben
Primary outcomes (1)
- measure
- sensitivity and specificity per patient analysis
- timeFrame
- Up to 6 months after [18F]Florbetaben PET/CT scanning
- description
- Sensitivity and specificity of \[18F\]Florbetaben PET/CT for the diagnosis of subjects with clinical, laboratory, radiological, or histopathological evidence of amyloidosis
Secondary outcomes (3)
- measure
- sensitivity and specificity per organ analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is over 19 years old and male or female of any race/ethnicity * Subject has been diagnosed with multiple myeloma by a hemato-oncology specialist * Subject has undergone clinical, laboratory, or imaging work-up if amyloidosis is suspected * Subject has voluntarily agreed to participate in the study Exclusion Criteria: * Subject or subject's legally acceptable representative does not provide written informed consent. * Female subject is pregnant or nursing. Exclusion of the possibility of pregnancy is made by one of the following: 1) Woman is physiologically post-menopausal (cessation of menses for more than 2 years), 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy, or 3) if the woman is of childbearing potential, a serum or urine pregnancy test performed within 24 hours immediately prior to administration of \[18F\]Florbetaben has to be negative and the women is advised to apply contraceptive measures during her participation in this study. * Subject has concurrent severe and/or uncontrolled and/or unstable medical disease (which could compromise participation in the study) in the judgment of the investigator. * Subject has received any investigational drugs or devices within four weeks prior to the study enrollment. * Subject has been previously included in this study. * Subject has any other condition or personal circumstances that, in the judgment of the investigator, might make collection of complete data difficult or impossible. * Subject is allergic to Florbetaben or any of ingredients of Florbetaben
References
Publications (0)
Data not yet available
No reference posted for this study.