N/A N=21 Diagnostic

Imaging Kidney Transplant Rejection Using Ferumoxytol-Enhanced Magnetic Resonance

Renal Transplant Rejection

Bottom Line

View on ClinicalTrials.gov: NCT02006108 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Radiologically Detectable Differences in Signal Intensity Between Healthy and Rejected Kidneys, Measured Using T2* Maps — 31.1; 23.3 ms (delayed postcontrast scans)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Feraheme (Drug); MRI-GE Healthcare 3 Tesla magnet (Other)
Age: Pediatric, Adult · 8+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Radiologically Detectable Differences in Signal Intensity Between Healthy and Rejected Kidneys, Measured Using T2* Maps	31.1; 23.3	—
SECONDARY Correlation of Cell-bound Iron Quantities on QSM Sequences With Macrophage and Iron Stains on Histopathology	—	—

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.

Eligibility Criteria

Inclusion Criteria

Completed solid organ transplant with referral for transplant follow-up

Exclusion Criteria

Exclusion criteria comprise MR-incompatible metal implants, need of sedation (since an anesthesia is not supported by this), claustrophobia or hemosiderosis/hemochromatosis.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02006108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.