Each study's protocol has guidelines for who can or cannot participate in the
study. These guidelines, called eligibility criteria, describe characteristics
that must be shared by all participants. The criteria differ from study to
study. They may include age, gender, medical history, and current health
status. Eligibility criteria in an imaging trial may differ as compared to a
treatment trial. Some examples of how imaging clinical trials might have
special eligibility requirements follow:
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For screening trials, family history and lifestyle might be factors in
determining eligibility. For example, a researcher might be trying to find an
answer to the question "Is the new technique of
digital mammography
more or
less effective at finding breast cancer than traditional film mammography in
women that have a family history of breast cancer?" For this study, researchers
would be looking for women who have a family history of breast cancer, but have
not had suspicious mammograms or lumps previously.
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For diagnostic trials, eligible participants might have a suspicious lump or
symptoms, be newly diagnosed with the type of cancer being studied, and not
have received any type of treatment. For instance, a trial might compare a
traditional diagnostic technique, such as a
CT scan, with a diagnostic
technique such as
PET or MRI to see if they are as accurate or if they can
provide new, valuable information.
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Imaging trials are sometimes part of other trials, such as drug treatment
trials. In order to participate in such an imaging clinical trial, a treatment
procedure would have to be followed. One example might be a trial using imaging
to see if the blood supply to a tumor is reduced by a particular drug, which
may slow or stop tumor growth. Participants in the imaging trial would need to
meet the eligibility requirements and be enrolled in the treatment part of the
trial.
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