Multiple MyelomaPETNCT03779815
Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography
A study testing [18F]Florbetaben in people with Multiple Myeloma, run by Ulsan University Hospital at 1 site in South Korea.
Trial summary
[18F]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- [18F]Florbetaben
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Aug 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
[18F]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis.
Read the detailed description
Diagnostic validity of [18F]Florbetaben PET for detecting amyloidosis will be assessed in subjects with multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- [18F]Florbetaben
- Keywords
- multiple myeloma, amyloidosis, Florbetaben
- Medical subject headings
- Multiple Myeloma, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FlorbetabenDrug
Also called neuraceq
- Drug: [18F]Florbetaben
- [18F]Florbetaben PET/CT Imaging for detecting amyloidosis in multiple myeloma
- Other name: Neuraceq
- Amount: 300 MBq ± 20% bolus, 10mL intravenously
| Study group | Role | What they receive |
|---|---|---|
| [18F]Florbetaben PET/CT imaging | Experimental | * 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) Receives: Drug: [18F]Florbetaben |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity per patient analysis
Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of subjects with clinical, laboratory, radiological, or histopathological evidence of amyloidosis
Measured: Up to 6 months after [18F]Florbetaben PET/CT scanning
Secondary outcomes (3)
sensitivity and specificity per organ analysis
Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of affected organs with clinical, laboratory, radiological, or histopathological evidence of amyloidosis
Measured: Up to 6 months after [18F]Florbetaben PET/CT scanning
Correlation with severity
Correlation of [18F]Florbetaben activity with clinical/radiological/histopathological indices of amyloidosis severity
Measured: Up to 6 months after [18F]Florbetaben PET/CT scanning
Adverse events
Adverse events will be monitored.
Measured: Up to 28 days after [18F]Florbetaben PET/CT scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start20 Aug 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Cheol Jo, Ulsan University Hospital
- Investigators
- Jae-Cheol Jo, PhD, Principal investigator, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779815
- Sponsor's protocol ID
- UUH-2018-05-034-001
- Acronym
- PET
- Status last verified
- Apr 2019
- First submitted
- 12 Sep 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03779815
- Acronym / sponsor ID
- PET / UUH-2018-05-034-001
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, amyloidosis, Florbetaben
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
[18F]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis.
Detailed description
Diagnostic validity of [18F]Florbetaben PET for detecting amyloidosis will be assessed in subjects with multiple myeloma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]Florbetaben PET/CT imaging | Experimental | Drug: [18F]Florbetaben* 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) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FlorbetabenAlso: neuraceq* Drug: [18F]Florbetaben * [18F]Florbetaben PET/CT Imaging for detecting amyloidosis in multiple myeloma * Other name: Neuraceq * Amount: 300 MBq ± 20% bolus, 10mL intravenously | Drug | [18F]Florbetaben PET/CT imaging |
Primary outcome
sensitivity and specificity per patient analysis
Time frame: Up to 6 months after [18F]Florbetaben PET/CT scanning
Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of subjects with clinical, laboratory, radiological, or histopathological evidence of amyloidosis
3 secondary outcomes
sensitivity and specificity per organ analysis
Time frame: Up to 6 months after [18F]Florbetaben PET/CT scanning
Correlation with severity
Time frame: Up to 6 months after [18F]Florbetaben PET/CT scanning
Adverse events
Time frame: Up to 28 days after [18F]Florbetaben PET/CT scanning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Cheol Jo, PhD principal investigator
Ulsan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]Florbetaben in people with Multiple Myeloma, run by Ulsan University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity per patient analysis (time frame: Up to 6 months after [18F]Florbetaben PET/CT scanning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.