Research Protocol ACRIN 6678
Learning About PET/CT Scans:
Can PET/CT scans provide helpful information
for the treatment o...
Research Protocol ACRIN 6678
Purpose of the Study
The main goal of this research study is:
To determine if PET/CT scans ca...
Research Protocol ACRIN 6678
What is a PET Scan?
 PET is a nuclear medicine imaging exam that produces a 3-D
image that p...
Research Protocol ACRIN 6678
What is a PET/CT Scan?
 Many PET scanners include a CT scanner, giving
us PET/CT.
 The comb...
Research Protocol ACRIN 6678
Participation Requirements
 Participants will be active in the study
approximately 6 months ...
Research Protocol ACRIN 6678
Participation Requirements cont.
Your doctor may also decide to stop your participation in
th...
Research Protocol ACRIN 6678
Study Procedures
Study participants will be assigned into one of two
groups as randomly chose...
Research Protocol ACRIN 6678
Study Procedures cont.
 Group A participants will undergo 3 PET/CT scans.
• Scans 1 and 2 – ...
Research Protocol ACRIN 6678
Study Procedures cont.
About the CT Scans:
 All study participants will undergo routine
foll...
Research Protocol ACRIN 6678
Standard Medical Procedures
The following are part of standard cancer care:
 Chemotherapy
 ...
Research Protocol ACRIN 6678
Treatment Options
As part of this study, additional PET/CT scans will
be performed.
If you ch...
Research Protocol ACRIN 6678
Benefits of Participation
While this study may or may not be of direct medical benefit
to you...
Research Protocol ACRIN 6678
Risks Associated with Participation
 If you choose to participate in this study, there
are p...
Research Protocol ACRIN 6678
Risks Associated with Participation cont.
 These risks would be in addition to the side
effe...
Research Protocol ACRIN 6678
Patient Confidentiality
 All participant personal information will be kept
confidential.
 W...
Research Protocol ACRIN 6678
Patient Confidentiality cont.
Organizations such as the following may
inspect or copy your re...
Research Protocol ACRIN 6678
Cost of Participation
Please speak with your doctor or research
associate about specific deta...
Research Protocol ACRIN 6678
If you have questions…
 Regarding the research study:
• Contact the study doctor or research...
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Research Protocol ACRIN 6678 Learning About PET/CT Scans:

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Research Protocol ACRIN 6678 Learning About PET/CT Scans:

  1. 1. 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.
  2. 2. 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. Approximately 228 people will participate.
  3. 3. 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.
  4. 4. 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.
  5. 5. Research Protocol ACRIN 6678 Participation Requirements  Participants will be active in the study approximately 6 months (24 weeks) while undergoing chemotherapy.  Following treatment, study participants will need to schedule follow-up doctor visits as their doctor recommends.  Participation is voluntary and may be stopped at any time.
  6. 6. 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.
  7. 7. Research Protocol ACRIN 6678 Study Procedures Study participants will be assigned into one of two groups as randomly chosen by a computer:  Group A or Group B. Participants in each group will undergo:  3 PET/CT Scans.
  8. 8. 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 • Scan 3 – after the first cycle of chemotherapy  Group B participants will undergo 3 PET/CT scans. • Scan 1 – before cancer treatment • Scan 2 – after the first cycle of chemotherapy • Scan 3 – after the second cycle of chemotherapy
  9. 9. 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.
  10. 10. 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).
  11. 11. Research Protocol ACRIN 6678 Treatment Options As part of this study, additional PET/CT scans will be performed. 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.
  12. 12. 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 treatment)  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.
  13. 13. 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
  14. 14. 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.
  15. 15. 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)
  16. 16. 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).
  17. 17. 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.
  18. 18. 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).

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