Imaging Kidney Transplant Rejection Using Ferumoxytol-Enhanced Magnetic Resonance

NCT02006108 | Completed Results

• 1 other identifier: 94027
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to develop a non-invasive imaging test for in vivo detection of kidney transplant rejection. The hypotheses are that 1) Ferumoxytol-MRI can generate accurate estimates of tissue iron concentrations and tissue macrophages. 2) The signal given by a renal allograft on Ferumoxytol-MRI demonstrates significant differences between rejected and non-rejected transplants.

Conditions

Renal Transplant Rejection

Keywords

kidney; transplant; rejection; Feraheme; ferumoxytol

Outcome Measures

Primary Outcomes (1)

• Radiologically Detectable Differences in Signal Intensity Between Healthy and Rejected Kidneys, Measured Using T2* Maps

  According to the study hypothesis, macrophage infiltration into rejected kidneys will be significantly greater than in healthy kidneys; since macrophages are expected to phagocytose injected iron, there should be a detectable difference in signal intensity between healthy and rejected organs. This can be evaluated using semiquantitative T2\* maps.

  24 hours to 7 days

Secondary Outcomes (1)

• Correlation of Cell-bound Iron Quantities on QSM Sequences With Macrophage and Iron Stains on Histopathology

  3 weeks

Study Arms (1)

Feraheme

EXPERIMENTAL

Intravenous injection of Feraheme, 5 mg Fe/kg Interventions: Drug: Feraheme Procedure: MR Scan

Drug: Feraheme; Other: MRI-GE Healthcare 3 Tesla magnet

Interventions

Feraheme DRUG

Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging

Also known as: Ferumoxytol

Feraheme

MRI-GE Healthcare 3 Tesla magnet OTHER

All patients will undergo

Also known as: Magnetic Resonance Imaging, MR Imaging

Feraheme

Eligibility Criteria

• Age: 8 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Completed solid organ transplant with referral for transplant follow-up

Sponsors & Collaborators

• Stanford University: lead
• Lucile Packard Children's Hospital: collaborator

Study Sites (1)

Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Ferrosoferric Oxide; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. Heike E. Daldrup-Link
• Organization: Stanford University, Department of Radiology

emisquez@stanford.edu

650-497-8601

Study Officials

• Heike E Daldrup-Link, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: December 9, 2013
• Study Start: November 27, 2012
• Primary Completion: April 11, 2017
• Study Completion: April 11, 2017
• Last Updated: May 11, 2018
• Results First Posted: June 27, 2017

Record last verified: 2018-04

Locations

US (1)