NCT01815086

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 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
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day 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

4.6 years

First QC Date

March 13, 2013

Last Update Submit

September 17, 2013

Conditions

AL Amyloidosis

Keywords

RadioimmunoimagingAL AmyloidosisPET/CT

Outcome Measures

Primary Outcomes (1)

  • 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.

    Five days post PET/CT scan

Study Arms (1)

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.

Biological: Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)

Interventions

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)

124I-labeled anti-amyloid mAb 11-1F4

Eligibility Criteria

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

You may qualify if:

  • Patients with a confirmed diagnosis of AL amyloidosis.

You may not qualify if:

  • New York Heart Association class IV
  • 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

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 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
Professor of Mediciine; Head, Human Immunology & Cancer Program

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 20, 2013

Study Start

December 1, 2008

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 18, 2013

Record last verified: 2013-09

Locations

US(1)