Download Consent for Research Study A study for patients diagnosed with

Consent for Research Study
A study for patients diagnosed with locally
advanced breast cancer
Learning if the imaging agent, [18F] fluorothymidine
(FLT), helps to predict the success
chemotherapy treatment
A research study coordinated by the American
College of Radiology Imaging Network (ACRIN)
Purpose of the Study
• This research study is being done to evaluate
the imaging agent [18F] fluorothymidine, often
referred to as “FLT”.
• The study doctors want to know if FLT is
helpful for predicting how well chemotherapy
shrinks breast cancer tumor.
• 54 participants will be involved in this study
Participation Requirements
Your direct participation will consist of:
• A screening visit
• Three FLT-PET imaging sessions
• Just before you start chemotherapy treatments
• One week after you start chemotherapy treatments
• After chemotherapy treatments have been completed
Participation Requirements
• Research studies will be done on the tissue
removed during your surgery after you
complete your chemotherapy treatments.
• Your participation is voluntary, you may stop
at any time
Participation Requirements
• Your participation in this study may be stopped at any
time by the study doctor or the sponsor without your
consent. The reasons might include:
– The study doctor thinks it necessary for your health or
safety;
– You have not followed study instructions;
– The sponsor has stopped the study;
– Administrative reasons require your withdrawal
About FLT
• FLT is used to help image the growth of tumor cells
and may be used to show how well chemotherapy is
working
• FLT is an investigational imaging agent, which means
that it has not been approved by the U. S. Food and
Drug Administration (FDA)
• It is hoped that FLT-PET imaging done before and
during chemotherapy will show whether your tumor
is staying the same, growing, or shrinking
Study Procedures
•
Screening Visit – this will take place within 4 weeks before
beginning the first imaging session to determine whether you
meet the study entrance requirements. Also:
– A medical history will be taken
– You will have a physical exam, and your vital signs (temperature, blood
pressure, heart rate and blood oxygen level) may be recorded. Some of
this information may be taken from your medical records
– Blood will be drawn to test your blood chemistry and liver function
– If some of these tests have been done previously and the results are
available in your medical records, they will not be repeated
Study Procedures
• FLT-PET Scans - There will be three imaging sessions
– For each scan, you:
• Will receive an IV injection of FLT through an IV.
• Will remain still for about an hour and a half while images of your chest
and then your whole body are taken
• About 35 minutes later, (two hours after the injection) you will return to
the PET scanner for a second whole body image, which will take about
30 minutes
Study Procedures
Tumor tissue collection
• During your surgery, which is part of standard
care, any remaining tumor will be removed.
This tissue will be tested for tumor growth and
to help identify tumor staging.
• All your personal information will be removed
from the sample.
Risks of Participation
• FLT is NOT an FDA approved drug
• There are no known side effects from earlier
studies using FLT.
• As with all medications, there is a risk of
allergic reaction
Benefits of Participation
• This is not a treatment study and you are not
expected to receive any direct medical benefits
from your participation.
• The information learned from this study may
lead to better treatment in the future for
patients with breast cancer
Patient Confidentiality
• Every effort will be made to keep your personal
information confidential.
• Confidential copies of your records during your
participation will be kept at the participating hospital
or medical center.
• All participant research information sent to ACRIN
headquarters in Philadelphia, PA will be coded so that
study participants cannot be identified.
Patient Confidentiality cont.
• Organizations such as the following may inspect or copy
your records at the participating hospital or medical
center for quality assurance and data analysis:
•
•
•
•
ACRIN
Food and Drug Administration (FDA)
National Cancer Institute (NCI)
Institutional Review Board (IRB)
Costs and Payment
• Taking part in this study will not lead to added costs
to you or your insurance company
• While ACRIN does not pay for participation in
studies, reasonable travel expenses will be
reimbursed:
– $180 for completion of all 4 scans
– $45 for each completed scan if all 4 were not completed
Participation Rights
• Taking part in this study is voluntary
• You may choose not to take part or leave the study at any
time. Leaving the study will not result in any penalty or
loss of benefits
• Participation in this study may delay treatment by up to 1
week
• If you leave the study before the final visit, you may be
asked by the study doctor to make a final visit for some
of the end of study procedures
If you have questions:
• Regarding the 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)
• Regarding general cancer research:
– National Cancer Institute:
• www.cancer.gov; 1800 4 CANCER
– American Cancer Society:
• www.cancer.org; 1 800 ACS 2345