MRI of lymph nodes in patients with
lung and breast cancer: evaluation of a
new contrast agent for tumor detection
(Combidex protocol)
David A. Bluemke, M.D., Ph.D.
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No Charge Patient Studies, MRI
Introduction
Objectives
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MRI Evaluation -- no cost MR examination
Advanced Magnetics is sponsoring a patient study at the Johns Hopkins
Hospital for which MRI examinations of the chest are performed without charge
to the patient. MRI is known to be highly sensitive for detecting lymph node
metastasis from tumors such as breast cancer or lung cancer. Patients are
actively being recruited for this study. There are several criteria that must
be met for participation:
Individuals with known breast cancer or lung cancer
Patients who will undergo surgery for their breast or lung cancer
Patients cannot have received an investigational drug within 30 days
Patients who meet these entry criteria will be considered for enrollment.
Study patients will be reimbursed for their time and expenses involved in
participation. Patients are required to have routine blood tests just before
the MRI, as well as at 24 hours after the test. The MRI study is performed at
the Johns Hopkins Hospital in Baltimore, MD, using the highest quality
available MRI scanners.
The study is described in detail below. For further information, please
contact:
Dr. David A. Bluemke
dbluemke@rad.jhu.edu
Department of Radiology
The Johns Hopkins Hospital, Baltimore, MD
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I. INTRODUCTION
The evaluation or regional and distant lymph nodes provides critical
information for treatment planning and determining prognosis in patients with
cancer. Current imaging modalities have relatively low sensitivity and
specificity for detection of lymph node metastases. MR imaging is limited, as
is radiography and CT, by low tumor-lymph node contrast. Both CT and
ultrasound are limited because the criterion for abnormality is based on
size. Size discrimination presents a serious disadvantage since the majority
of lymph node metastases measure less than 5 mm, and only 13% were larger
than 10mm. MR diagnosis of nodal involvement is also based on size criteria.
Thus, the development of a tissue-specific contrast agent is critical if MR
imaging is to improve sensitivity in cancer staging.
Advanced Magnetics, Inc. is developing a new, biodegradable ultrasmall
superparamagnetic iron oxide particle, Combidex, which is covered with a low
molecular weight dextran for use in contrast enhanced MRI. Pre-clinical and
clincial studies suggest that phagocytosis of the agent by cellular elements
of the reticuloendothelial system (liver, spleen, bone marrow, and lymph
nodes) may yield useful post-administration image contrast in those tissues.
The results from a Phase II study in patients with head and neck cancers
suggest that Combidex has the potential to discriminate normal lymph nodes
from metastatic nodes.
II. OBJECTIVES
The objective of this study is to examine the safety and efficacy of Combidex
for MR imaging of lymph nodes. The specific objectives are: to determine the
efficacy of Combidex for the diagnosis of lymph node metastases from head and
neck, lung, breast, abdomen, and pelvic carcinoma by an evaluation of the
sensitivity and specificity of MRI with Combidex when compared to histology;
to evaulate the safety of Combidex in a broad patient population by an
analysis of changes in pre- and post-administration blood chemistry,
urinalysis, vital signs, results of physical examinations and incidence of
adverse events; to determine the role of Combidex in the staging of cancer;
and to determine the clinical utility of Combidex in patient diagnosis and
management.
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