AL AmyloidosisPhase 1NCT01815086
Radioimmunoimaging of Light Chain (AL) Amyloidosis
A Phase 1 study testing Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg) in people with AL Amyloidosis, run by University of Tennessee at 1 site in United States.
Trial summary
The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- AL Amyloidosis
- What is being tested?
- Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jul 2013
- Phase
- Phase 1
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a confirmed diagnosis of AL amyloidosis.
Who cannot join
- New York Heart Association class IV
- On renal dialysis
- Serum antibodies to mouse protein
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
About this study
Official title: Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody (mAb) Murine (Mu) 11-F4
The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.
Read the detailed description
To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, given over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 days after infusion of the antibody. A 5-ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.
- Conditions
- AL Amyloidosis
- Being tested
- Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
- Keywords
- Radioimmunoimaging, AL Amyloidosis, PET/CT
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)Biological
Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
| Study group | Role | What they receive |
|---|---|---|
| 124I-labeled anti-amyloid mAb 11-1F4 | Experimental | 124I-labeled anti-amyloid mAb 11-1F4 will be infused on day 0. Two and 5 days later, PET/CT scans will be performed. Receives: Biological: Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT in up to 30 patients with AL amyloidosis.
PET/CT images will be taken 2 and 5 days post-radiolabeled antibody infusion to evaluate if there is organ/tissue uptake (greater than blood pool) and to determine if the presence of radiolabeled antibody correlates with clinically proven amyloid deposition.
Measured: Five days post PET/CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startDec 2008
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AL AmyloidosisStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Solomon, FDA Office of Orphan Products Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815086
- Sponsor's protocol ID
- IND 100472
- Other IDs
- 1R01FD003420-01A1
- Status last verified
- Sep 2013
- First submitted
- 13 Mar 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody (mAb) Murine (Mu) 11-F4
- ClinicalTrials.gov ID
- NCT01815086
- Acronym / sponsor ID
- IND 100472
- Conditions
- AL Amyloidosis
- Keywords
- Radioimmunoimaging, AL Amyloidosis, PET/CT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Mar 2013 (estimated)
- 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.
The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.
Detailed description
To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, given over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 days after infusion of the antibody. A 5-ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 124I-labeled anti-amyloid mAb 11-1F4 | Experimental | Biological: Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)124I-labeled anti-amyloid mAb 11-1F4 will be infused on day 0. Two and 5 days later, PET/CT scans will be performed. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a confirmed diagnosis of AL amyloidosis.
Key exclusion criteria (3 listed)
- New York Heart Association class IV
- On renal dialysis
- Serum antibodies to mouse protein
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 |
|---|---|---|
| Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg) | Biological | 124I-labeled anti-amyloid mAb 11-1F4 |
Primary outcome
Determination of the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT in up to 30 patients with AL amyloidosis.
Time frame: Five days post PET/CT scan
PET/CT images will be taken 2 and 5 days post-radiolabeled antibody infusion to evaluate if there is organ/tissue uptake (greater than blood pool) and to determine if the presence of radiolabeled antibody correlates with clinically proven amyloid deposition.
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 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg) in people with AL Amyloidosis, run by University of Tennessee at 1 site in United States.
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 1 inclusion and 3 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 Sep 2013. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determination of the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT in up to 30 patients with AL amyloidosis. (time frame: Five days post PET/CT scan). 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 Sep 2013.