research protocol acrin 6684

Consent for Research Study

A study for patients newly diagnosed with advanced glioblastoma (brain cancer):

Learning whether a PET scan with F-fluoromisonidazole (FMISO) can help doctors tell if a

tumor is getting enough oxygen for treatment to be effective

Research Protocol ACRIN 6684

A research study coordinated by the American College of Radiology Imaging Network (ACRIN)

Purpose of the Study The main goal of this research is:

• To add to doctors’ knowledge of how a tumor’s lack of oxygen (hypoxia) and cancer treatments are related in order to best manage treatment for people with brain cancer

About 50 people from 4 to 10 institutions will

take part in this study.


Participation Requirements You will be involved with the study’s imaging procedures

for about 12 weeks after you are enrolled. Following completion of the PET scanning you will

resume follow-up scanning according to your doctor’s recommendations.

Your treating doctor will provide information on your health and disease status to study doctors for up to 3 years after study completes enrollment

Your participation is voluntary; you may stop at any time.


Participation Requirements cont.

The study may be stopped at any time by your

study doctor or administrators if:• Your health or safety is at risk• The imaging agent is no longer available• New information becomes available that might

change your mind about participating• An administrative decision is made by the study

doctor or affiliated agencies


Study Procedures PET scans with FMISO performed during the study:

• Within 2 weeks prior to starting treatment for your brain cancer• Within 1 week prior to the start of treatment (only 15 participants

will undergo this additional PET scan)• About 3-4 weeks after starting your treatment• 3-5 weeks after you have completed treatment

MRI scans performed:• You will undergo 1 more MRI scan with gadolinium contrast

during your treatment than if you choose not to participate in the study


Study Procedures cont. Blood samples taken during the study:

• Small amounts of blood will be taken during each of your scanning visits.

You may undergo the FMISO PET scans and MRI scans on the same day or on separate days, according to your doctor’s recommendations and your preference.


Imaging Timeline

Visit 1: Identify eligible patient and consent them to trial

Visit 2: PET and MRI Scans

1 to 14 days before tx begins

Visit 2 A: For first 15 patients

PET Scan

1 to 7 days after first PET scan and before tx begins


3 wks (21 days) after the start of tx


4 weeks (28 days) after tx

About PET Scans with FMISO PET is a nuclear medicine imaging technique that

produces a 3-D image of cell function in the body. A PET scan is performed after a small amount of a

radioactive drug (called a “radioligand”) is injected into the body to help identify differences between healthy and diseased tissue.

FMISO, the new radioligand used in this study, has been helpful in evaluating how well a tumor is getting oxygen, which may affect how well it responds to radiation and chemotherapy.


About New MRI Image Techniques An MRI uses powerful magnets and radio waves linked

to a computer to create clear and detailed cross-sectional images of the body.

A liquid-like dye, called a contrast agent, is used during an MRI to help imaging machines create pictures of the body’s organs and bones.

Gadolinium, a standard contrast agent used during MRI scans, will help doctors view your brain tumor.

The MRI will measure characteristics of your tumor that seem related to whether it receives enough oxygen, including changes in blood flow, blood volume, and blood vessel size.


Blood Sample Procedures Blood samples will be taken from an IV catheter

each time you undergo a PET This catheter will be separate from the one used

to inject the FMISO or the gadolinium contrast.• The amount of FMISO in the blood samples helps

doctors determine how much FMISO is being absorbed by the tumor, which tells them how much oxygen the tumor is getting.


Study Procedure

This study will also use a second method of measuring FMISO absorption that compares the amount of FMISO shown on the tumor PET scan with the amount shown in the normal area of the brain.• If this more convenient method is found to accurately

measure the FMISO absorption, doctors may be able to use it to replace the blood sampling method.


Standard Medical Procedures The following are part of regular cancer care for

glioblastoma:• Chemotherapy (temozolomide)• Radiation therapy• One MRI scan with gadolinium contrast prior to chemoradiation

and after completion of chemoradiation• Physical examination• Short mental health examinations• Neurologic examination• Routine blood laboratory studies• Pregnancy test (if applicable)


Treatment Options If you choose not to participate, the care you

receive will not be affected.

You could undergo PET and MRI scans without participating in this study; please discuss this and other options with your treating doctor


Benefits of Participation Although this study is not designed to be of direct

medical benefit to you, your participation could:• Give you the satisfaction of being part of an effort with the

potential to benefit other patients with brain cancer in the future• Help doctors determine the best treatment approaches for

people with certain types of brain cancer • Help treatments work better in brain cancers that are difficult to

treat The study team will provide a supportive environment

for participants, assist in scheduling scans, answer procedure questions, and make their involvement as comfortable as possible.


Risks Associated With Participation If you choose to participate in this study, you may be at

risk for side effects. Your doctor or research associate will discuss these

with you in more detail. Many side effects go away shortly after the imaging

scan is stopped and IV catheters are removed. Other drugs may be given to make side effects less

serious and uncomfortable. If you are pregnant, are breastfeeding, or plan to

become pregnant or father a child, you should not participate in this study due to reproductive risks.


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 following locations:

• The participating hospital or medical center• American College of Radiology Imaging Network

(ACRIN) headquarters in Philadelphia, PA


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)


Cost of Participation Taking part in this study will not lead to added

costs to you or your insurance company.

Please speak with your doctor or research associate about specific details regarding reimbursement, any added costs, or insurance problems.


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)

• Regarding general cancer research: – Call the NCI’s Cancer Information Service at

1-800-4-CANCER (1-800-422-6237).


research protocol acrin 6684

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