Download Consent Flip Chart - Cervical

Consent for Research Study
A study for Women with Advanced Cervical Cancer:
Learning whether a PET/CT scan using an imaging agent
called FDG (Fluorodeoxyglucose) 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 goal of this research study is:
•
To determine if a PET-CT scan using the
imaging agent (Fluorodeoxyglucose) FDG
can find cancer that may have spread to your
lymph nodes.
ACRIN 6671/GOG 0233
Participation Requirements
 You will be in this study during the entire time
you are receiving the treatment.
 You will be asked to visit the office for follow-up
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:
• It could benefit your health
• Funding for the study has stopped
• Your health worsens
• New information becomes available
ACRIN 6671/GOG 0233
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:
o It is the standard treatment at your center
o A finding was visible on the PET/CT that could
not be biopsied
ACRIN 6671/GOG 0233
Study Procedures cont.
 Surgery (lymph nodes 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
o You will remain in the hospital until you have
recovered from your surgery
o 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 scan uses a small amount of a radioactive imaging agent to show
differences between healthy and diseased tissue. The most
commonly used agent – and the one used for this study – is called
FDG (fluorodeoxyglucose), so the test is sometimes called an FDGPET 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
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
ACRIN 6671/GOG 0233
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:
• PET/CT scans
• Imaging Agent
• 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 using FDG
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 treatment if a better
option is available.
ACRIN 6671/GOG 0233
Patient Confidentiality
 Every effort will be made to keep your personal
information confidential.
 Organizations such as American College of
Radiology Imaging Network (ACRIN),
Gynecology Oncology Group (GOG), Food and
Drug Administration (FDA), 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