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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
Consent for Research StudyA 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).
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.
To determine if the investigative contrast agent (the scientific name is ferumoxtran-10) helps MRI scans locate cancer in lymph nodes.Purpose of Study
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.Participation Requirements
It could benefit your health
Funding for the study has stopped
Your health worsens
New information becomes availableParticipation Requirements cont.
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)Study Procedures
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 daysStudy Procedures cont.
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 cellfunction (PET).About the PET/CT Scan
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.About MRI Scans
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.About MRI Scans cont.
Your doctor can talk to you about different treatment options for your cervical cancer other than this research study.Treatment Options
The risk of side effect is associated with the following procedures:
Contrast agent (ferumoxtran-10)
Surgery (lymph node dissection)
If you are pregnant or plan to become pregnant, you should not participate in this study due to reproductive risks.Risks Associated with Study Participation
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 availableBenefits of Participation
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.Patient Confidentiality
Please speak with your doctor or research associate about specific details regarding reimbursement, any added costs or insurance problems.Cost of Participation