Biomedical Engineering Reference
In-Depth Information
TABLE 7.3 Nanomaterials as MRI Contrast Agents in Clinical Trials
Chemical
composition/
name
Brand
name
Application
Company
Status
Dextran coated
superparamag-
netic iron oxide,
SPIO (ferumox-
tran-10)
Combidex/
Sinerem
Cancerous
lymph node
AMAG
Pharmaceuticals,
Inc
Phase III
Carboxy dextran-
coated SPIO
(ferucarbotran)
Supravist
Blood pooling
detection with
MRA
Bayer Schering
Pharm AG
Phase III
Polyglucose
sorbitol
carboxymethyl
ether-coated SPIO
(ferumoxytol)
-
Nervous
system
disease; brain
neoplasm;
peripheral
artery disease
AMAG
Pharmaceuticals,
Inc
Phase II
Citrate coated
very small SPIO
VSOP-
C184
Blood pooling
detection with
MRA
Charite-Univer-
sitatsmedizin
Berlin
Phase I
Radiolabeled
HER-2 antibody
ABY-025
Breast cancer
Antibody
Holding AB
Phase I
Although Combidex
®
has been approved for use in some EU countries, it
has had difficulty gaining widespread regulatory approval due to a high false
positive rate.
3
In a recent multicenter study that evaluated the use of Combidex
®
for MRI to identify lymph node metastases occurring outside the normal area,
pelvic lymph node dissection in 296 patients with prostate cancer
254
resulted
in a 24.1% false positive rate causing unnecessary surgical interventions.
3
Fol-
lowing FDA advice, Combidex
®
is currently undergoing additional clinical tri-
als in an attempt to improve the safety and accuracy for specific applications.
3
These potential applications include the screening and assessment of therapeu-
tic response to “anti-inflammatory” interventions,
255
the imaging of brain and
pelvic neoplasms, lymph node staging in prostate cancer, and the prediction of
abdominal aortic aneurysm instability.
3
Two SPIONs are under clinical investiga-
tion as contrast agents for MR angiography (MRA). Supravist
®
(Ferucarbotran),
which is a T1 weighted reformulation of Resovist
®
that has been developed for
“positive” detection of blood pooling.
3
Supravist
®
has shown promising results
using both first pass and steady state angiography after bolus injection
256
and are
comparable to those achieved using gadolinium(Gd) based contrast agents.
257
Phase III clinical trials in patients with peripheral artery disease and renal vascu-
lar disease have been completed but not yet published.
258
A 7 nm citrate coated
