Download Research Protocol ACRIN 6678

Learning About PET/CT Scans:
Can PET/CT scans provide helpful information
for the treatment of non-small cell lung cancer?
Patient consent overview for participation in
a research study coordinated by the
American College of Radiology Imaging Network (ACRIN)
ACRIN is a member of the National Cancer Institute’s clinical trials cooperative group program and
supports multi-center research related to medical imaging at over 100 participating institutions.
Research Protocol ACRIN 6678
Purpose of the Study
The main goal of this research study is:
To determine if PET/CT scans can help doctors
decide if chemotherapy is working to control
lung cancer.
A minimum of 228 people will participate.
Research Protocol ACRIN 6678
What is a PET 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 use a small amount of a radioactive drug, or
tracer, to show differences between healthy tissue and
diseased tissue.
 The most commonly used tracer – and the one used for this
study – is called FDG (fluorodeoxyglucuse).
 The test is sometimes called an FDG-PET scan.
Research Protocol ACRIN 6678
What is a PET/CT Scan?
 Many PET scanners include a CT scanner, giving
us PET/CT.
 The combination of PET/CT provides the most
complete information about both anatomy (CT)
and cell function (PET).
 CT is a special type of X-ray machine that
produces detailed images of the organ -- or
anatomy -- of interest.
Research Protocol ACRIN 6678
Participation Requirements
 Participation could be anywhere between 1 to 12 months,
depending upon a participant’s schedule.
 Following treatment, study participants will need to
schedule follow-up doctor visits as their doctor
recommends. Medical care and treatment information
may be collected for 12 months after study enrollment.
 Participation is voluntary and may be stopped at any time.
Research Protocol ACRIN 6678
Participation Requirements cont.
Your doctor may also decide to stop your participation in
this study if:
 Your condition worsens
 You experience serious side effects from the
chemotherapy treatment
 The chemotherapy your doctor prescribes is not part of
the study.
 New information becomes available
 The study is stopped early due to lack of funds or lack
of patient participation.
Research Protocol ACRIN 6678
Study Procedures
Study participants will pick with their doctor to join
one of three study groups:
 Group A, Group B, or Group C
Participants in groups A and B will undergo:
 3 PET/CT Scans
Participants in group C will undergo:
 2 PET/CT scans
Research Protocol ACRIN 6678
Study Procedures cont.
 Group A participants will undergo 3 PET/CT scans.
– Scans 1 and 2 – will be performed within 14 days before
the cancer treatment begins
– Scan 3 – will be performed after the first cycle of
chemotherapy
 Group B participants will undergo 3 PET/CT scans.
– Scan 1 – will be performed before cancer treatment
– Scan 2 – will be performed after the first cycle of
chemotherapy
– Scan 3 – will be performed after the second cycle of
chemotherapy
Research Protocol ACRIN 6678
Study Procedures cont.
 Group C participants will undergo 2 PET/CT
scans.
– Scans 1 and 2 – will be performed within 7
days of each other before any cancer
treatment begins.
Research Protocol ACRIN 6678
Study Procedures cont.
About the CT Scans:
 All study participants will undergo routine
follow-up CT scans every six (6) weeks as
part of their cancer treatment. The scan does
not include contrast.
 The scan results will be reviewed by your
doctor for a maximum of eighteen (18) weeks.
Research Protocol ACRIN 6678
Standard Medical Procedures
The following are part of standard cancer care:
 Chemotherapy
 A diagnostic CT scan to evaluate your cancer
 One PET/CT scan or PET scan
 Physical Examination
 Pregnancy Test (if applicable).
Research Protocol ACRIN 6678
Research Trial Procedures
As part of this study, additional PET/CT scans will
be performed, along with additional CT scans.
If you chose not to participate:
 PET/CT scans can still be done, however you
would need to speak to your doctor about this and
other options
 The care you receive will not be affected.
Research Protocol ACRIN 6678
Benefits of Participation
While this study may or may not be of direct medical benefit
to you, your participation could:
 Help doctors learn more about how to best treat your
type of cancer and if the chemotherapy treatment is
working (after the 2nd cycle of chemotherapy)
 Allow doctors to see if PET/CT scans can help identify
lung cancer that has spread
 Ultimately help doctors determine the best treatment
for lung cancer patients.
Research Protocol ACRIN 6678
Risks Associated with Participation
 If you choose to participate in this study, there
are potential 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 Scans
• CT Scans
Research Protocol ACRIN 6678
Risks Associated with Participation cont.
 These risks would be in addition to the side
effects you may experience from the
chemotherapy treatment.
 If you are pregnant or plan to become pregnant
you should not participate in this study due to
reproductive risks.
Research Protocol ACRIN 6678
Patient Confidentiality
 All participant personal information will be kept
confidential.
 While you are in the study confidential copies of
your records will be stored in the following
locations :
– The participating hospital or medical center
– American College of Radiology Imaging
Network (ACRIN)
Research Protocol ACRIN 6678
Patient Confidentiality cont.
Organizations such as the following may
inspect or copy your records for quality
assurance and data analysis:




ACRIN Statistical Center
Food and Drug Administration (FDA)
National Cancer Institute (NCI)
Institutional Review Board (IRB).
Research Protocol ACRIN 6678
Cost of Participation
Please speak with your doctor or research
associate about specific details regarding
possible added costs or insurance related
concerns.
Research Protocol ACRIN 6678
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
for an Institutional Review Board (IRB) contact
 Regarding general cancer research:
• Call the NCI’s Cancer Information Service at
1-800-4-CANCER (1-800-422-6237).
Research Protocol ACRIN 6678