Transcript Patient consent form

Consent for Research Study
A Study for Women with Advanced Cervical Cancer:
Learning whether an MRI scan with an investigative
contrast agent (called ferumoxtran-10) or a PET/CT scan
can help doctors provide better treatment
This research is a collaborative effort between two
National Cancer Institute (NCI) cooperative groups:
Gynecologic Oncology Group (GOG) and the
American College of Radiology Imaging Network (ACRIN).
ACRIN 6671/GOG 0233
Purpose of Study
The main goals of this research study are:
1. To determine if a PET/CT scan, an MRI scan
using an investigative contrast agent, or both
can identify cancer that may have spread to
your lymph nodes.
2. To determine if the investigative contrast
agent (the scientific name is ferumoxtran-10)
helps MRI scans locate cancer in lymph nodes.
ACRIN 6671/GOG 0233
About the Investigative Agent
Ferumoxtran-10
The investigative contrast agent (ferumoxtron-10) is a
substance given through an injection a day before the MRI
exam.
 Other studies have shown that it may help to find
cancer in lymph nodes, which helps determine the
best treatment for patients.
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Ferumoxtran-10 was developed so that cancerous
lymph nodes could be seen more clearly on MRI scans.
ACRIN 6671/GOG 0233
Participation Requirements
 You will be in this study during the entire time
you are receiving treatment.
 You will be asked to visit the office for followup exams for five (5) years following
treatment.
 Your participation is voluntary and you may
stop at any time.
ACRIN 6671/GOG 0233
Participation Requirements cont.
Your doctor may decide to stop your
participation in this study if:
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It could benefit your health
Funding for the study has stopped
Your health worsens
New information becomes available
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Study Procedures
 PET/CT scans performed during the study:
• Scan 1 – prior to a biopsy and before you begin your chemo
radiation treatment
• Scan 2 – you may have a second PET/CT scan if:
– It is the standard treatment at your center
– a finding was visible on the PET/CT that could not be biopsied
 MRI (with the investigative contrast agent):
– One will be performed 24-36 hours after the injection of
the special contrast agent (ferumoxtran-10)
ACRIN 6671/GOG 0233
Study Procedures cont.
Surgery (lymph node dissection):
 Will be performed prior to beginning your chemo radiation
treatment
 Certain lymph nodes will be removed and examined to see
if your cancer has spread
• You will remain in the hospital until you have recovered
from your surgery
• Recovery from surgery usually takes approximately 1-3
days
ACRIN 6671/GOG 0233
About the PET/CT Scan
 PET is a nuclear medicine imaging exam that produces a 3-D
image that provides information about cell function in the body.
PET scans uses a small amount of a radioactive drug, or tracer, to show
differences between healthy and diseased tissue. The most commonly
used tracer – and the one used for this study – is called FDG
(fluorodeoxyglucose), so the test is sometimes called an FDG-PET scan.
 CT is a special type of x-ray machine that produces detailed
images of the body part of interest.
 Many PET scanners include CT scanners, thus giving us PET/CT
scanners. This combination provides the most complete
information about both anatomy (CT) and cell function (PET).
ACRIN 6671/GOG 0233
About MRI Scans
 Magnetic Resonance Imaging (MRI) uses a powerful magnet
to create radio frequency signals that a computer uses to make
detailed pictures of areas inside the body without the use of
radiation.
 For the MRI scan, you will receive an injection of the MRI
investigative contrast agent called ferumoxtran-10.
 Some participants (40 total) may choose to have another MRI
scan before having the MRI scan with the investigative
contrast agent.
ACRIN 6671/GOG 0233
About MRI Scans cont.
 The contrast drug helps to make any abnormal lymph nodes
easier to see on the MRI scan.
 You will have the injection between 24 and 36 hours before
the MRI scan. In rare cases, this may be done up to 48 hours.
The investigational agent that is being studied is called
ferumoxtran-10.
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Standard Medical Procedures
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Physical examination
Medical history, including pregnancy test
Tumor measurement
Blood tests
Chest x-ray
Electrocardiogram (ECG)
– records the electrical activity of the heart over time
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Treatment Options
 If you chose not to participate, the care you
receive will not be affected.
 Your doctor can talk to you about different
treatment options for your cervical cancer
other than this research study.
ACRIN 6671/GOG 0233
Risks Associated with Study Participation
 If you chose to participate in this study, you are at risk of side
effects. Your doctor or research associate will discuss these
with you in more detail.
 The risk of side effect is associated with the following
procedures:
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PET/CT scans
Contrast agent (ferumoxtran-10)
MRI scans
Surgery (lymph node dissection)
 If you are pregnant or plan to become pregnant, you should not
participate in this study due to reproductive risks.
ACRIN 6671/GOG 0233
Benefits of Participation
While this study may or may not be of direct medical
benefit to you, your participation could:
 Help doctors determine whether PET/CT and MRI scans
(using ferumoxtran-10) can identify cancer that has spread
to lymph nodes
 Help doctors determine the best treatment for patients with
cervical cancer
 Allow doctors to possibly change treatments if a better
option is available
ACRIN 6671/GOG 0233
Patient Confidentiality
 Every effort will be made to keep your personal information
confidential.
 Confidential copies of your records will be stored in the
following locations while you are on the study:
• The participating institution
• American College of Radiology (ACRIN)
• Gynecologic Oncology Group (GOG)
 Organizations such as ACRIN, GOG, Food and Drug
Administration (FDA), AMAG Pharmaceuticals (manufacturer
of ferumoxtran-10), National Cancer Institute (NCI) and the
Institutional Review Board (IRB) may inspect or copy your
records for quality assurance and data analysis.
ACRIN 6671/GOG 0233
Cost of Participation
 There is no additional cost to the patient for
participation in this study.
 Please speak with your doctor or research
associate about specific details regarding
reimbursement, any added costs or insurance
problems.
ACRIN 6671/GOG 0233
If you have questions…
 Regarding the research study:
• Contact the study doctor or research associate
 Regarding patients’ rights:
• Ask your study doctor or research associate who
you should contact at their Institutional Review
Board (IRB)
ACRIN 6671/GOG 0233