NCT00807872

Brief Summary

The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

3.2 years

First QC Date

December 11, 2008

Last Update Submit

September 17, 2013

Conditions

Primary Amyloidosis

Keywords

RadioimmunoimagingAL AmyloidosisPET/CT

Outcome Measures

Primary Outcomes (1)

  • Radioimmunoimaging of AL amyloid deposits by PET/CT

    10-14 days post infusion

Study Arms (1)

I-124 Mu 11-1F4 sterile injection

OTHER

Single arm study

Biological: 124I-labeled monoclonal antibody Mu 11-1F4

Interventions

124I-labeled monoclonal antibody Mu 11-1F4BIOLOGICAL

Single infusion of radiolabeled antibody: 2 mCi (1 mg)

Also known as: anti-amyloid radioimmunoimaging agent
I-124 Mu 11-1F4 sterile injection

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of AL amyloidosis

You may not qualify if:

  • New York Heart Association class IV
  • patient on renal dialysis
  • serum antibodies to mouse protein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

  • Wall JS, Kennel SJ, Stuckey AC, Long MJ, Townsend DW, Smith GT, Wells KJ, Fu Y, Stabin MG, Weiss DT, Solomon A. Radioimmunodetection of amyloid deposits in patients with AL amyloidosis. Blood. 2010 Sep 30;116(13):2241-4. doi: 10.1182/blood-2010-03-273797. Epub 2010 Jun 3.

    PMID: 20522711DERIVED

Related Links

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesParaproteinemias

Study Officials

  • Alan Solomon, MD

    University of Tennessee Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Alan Solomon, M.D.

Study Record Dates

First Submitted

December 11, 2008

First Posted

December 12, 2008

Study Start

December 1, 2008

Primary Completion

March 1, 2012

Study Completion

July 1, 2013

Last Updated

September 18, 2013

Record last verified: 2013-09

Locations

US(1)