Comparing Preoperative PET-CT With Integrated MR-PET Scanning of Gynecologic Cancers
If you agree to participate in this study you will be asked to undergo some tests and
procedures to confirm that you are eligible. Many of these tests and procedures are likely
to be part of regular cancer care and may be done even if it turns out that you do not take
part in the research study. If you have had some of these tests or procedures recently, they
may or may not have to be repeated. These tests and procedures include a medical history,
blood tests and a urine pregnancy test. If these tests show that you are eligible to
participate in the research study, you will be able to undergo a one time MR/PET imaging
session on the same day you are scheduled for a PET/CT. If you do not meet the eligibility
criteria, you will not be able to participate in this research study.
We will verify that your doctor has ordered a standard PET/CT scan as part of your regular
medical care. You will have that PET/CT scan at teh main MGH Boston campus. As part of the
PET/CT scan, you will have an injection of a radioactive material into your vein. The
radioactive material consists of glucose (sugar) that has been labeled as radioactive. Your
own doctor, the radiologist performing imaging and/or the PET/CT staff will explain this
type of scan to you in more detail. You will be asked to sign a separate consent form for
that PET/CT scan.
PET/CT scanning can make pictures of structures inside the body because the injected
radioactive material "lights up" on the pictures. This shows us details of organs, tissues,
blood vessels, and other structures in your body. The radioactive material breaks down and
leaves your body gradually through the urine. It takes about a day for the radioactive
material to exit your body completely. You will not receive an additional injection of
radioactive material for this MR-PET study.
You will have the standard PET/CT procedures and the study MR-PET scans on the same day.
After you have the PET/CT scan, you will travel to the MGH Charlestown facility for the
study MR-PET scan. It takes about 15 minutes to travel between the main MGH campus and the
MGH Charlestown facility. Although you must fast (no eating or drinking) before the PET/CT
scan, you do not have to fast before the MR-PET scan. You will be able to have a snack
before the scan, if you wish.
During the MR-PET Procedure: We will ask you some standard questions to make sure that you
can safely have an MRI. It is important that you take off anything that contains metal, such
as jewelry, piercings or zippers. You may need to put on a hospital gown. We will also ask
you to empty your bladder before the scan.
We will ask you to lie down on a narrow table. The table will slide you into the center of
the very large MRI scanner, which is shaped like a tunnel. The tunnel is a little wider than
your body. You will need to lie very still during the scanning process.
In order to help hold your head still, we may place foam pillows under and around your head.
The scanner makes loud banging and beeping noises when making pictures, so we will give you
earplugs or headphones to protect your ears.
The top and sides of the tunnel will be close to your face and body, which can make some
people uncomfortable. If you have ever experienced a fear of small spaces (claustrophobia),
please tell the MRI staff. You will be able to hear and speak to the research staff at all
times during the scan. We can stop the scan at any time, if needed.
First, we will make some pictures of your brain and/or whole body.
The PET scan will take place at the same time as the MRI scan using our new MR-PET scanner.
You will not need another injection of radioactive material for our MR-PET scan.
During scanning, we may ask you to do some activities with your hands, look at pictures,
listen to some sounds, or do other things. We will make pictures of your brain during these
activities to test different settings on the scanner.
After your study scans are complete, your time in the study will be over. The whole testing
session will take up to one and a half hours. You may feel a little bit tired afterwards, so
you can rest a bit before leaving the scanning area.
You will be in this research study for about up to one month-this includes the waiting
period until pathology results from the surgery are back. Your actual participation in the
study will only involve that one day when you receive both the PET/CT and PET/MR.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. PET/CT
To evaluate the diagnostic sensitivity and specificity of preoperative MR/PET versus PET/CT imaging in identifying metastases to pelvic lymph nodes, abdominal lymph nodes, or beyond in participants with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
Michael Birrer, MD, PhD
Massachusetts General Hospital
United States: Institutional Review Board
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