Renal Transplant Rejection Clinical Trial
Official title:
Non-invasive MR Imaging Diagnosis of Transplant Rejection
NCT number | NCT02006108 |
Other study ID # | 94027 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 27, 2012 |
Est. completion date | April 11, 2017 |
Verified date | April 2018 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | April 11, 2017 |
Est. primary completion date | April 11, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 40 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Lucile Packard Children's Hospital | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Lucile Packard Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Correlation of Cell-bound Iron Quantities on QSM Sequences With Macrophage and Iron Stains on Histopathology | To evaluate our ability to quantify cell-bound iron using the novel QSM sequence, we use histopathological data showing 1) the iron content of renal tissue sampled, and 2) the level of macrophage infiltration of the renal tissue. We will perform iron and macrophage stains in biopsy tissues in order to determine this. | 3 weeks |
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