Download Language to include in the protocol for research CT scans

CACTIS standard language for a protocol or study consent form for more information contact
Deborah Arnold at [email protected]
Studies Involving Research CT Scans
15.4 Studies Involving Research CT Scans
Language to include in the protocol for research CT scans

CACTIS: Are research subjects undergoing a CT scan?
Yes
No
If yes, describe the imaging procedure and, if possible, upload the imaging manual. Please complete the CACTIS
application: http://www.uphs.upenn.edu/radiology/research/labs/cactis/application/humans.html
Language to include in the consent form for studies involving research CT scans

CACTIS: Are research subjects undergoing a CT scan for research purposes?
Yes
No
If yes: A computed tomography (CT) scan is an imaging method that uses x-rays to create cross-sectional pictures of the
body. You will be asked to lie on a narrow table that slides into the center of the CT scanner. Depending on the study
being done, you may need to lie on your stomach, back, or side. Once you are inside the scanner, the machine's x-ray
beam rotates around you. It is important to remain still during the exam, because movement causes blurred images. You
may be told to hold your breath for short periods of time. The scans take between 10 -45 minutes depending on the test.
You will be asked to fill-out a screening form which asks questions about your medical history and any allergies you may
have.
Patient preparation for CT procedures (include in consent form and review with participant)
Head exams – For head CT exams you will be asked to remove glasses, hearing aids, dentures and earrings or any
metal that may interfere with the image.
Chest CT exams – You will be asked to raise your arms above your head during the procedure
Abdominal CT scans – You will be asked to raise your arms above your head during the procedure.
Patient preparation for CT exams that require contrast agents.
Oral and IV contrast agents may be given for abdominal CT scans to better visualize structures. If your study requires the
use of CT contrast agents you must have nothing to eat or drink for a period of four hours prior to the exam. It is important
to stay well hydrated prior to the four hours and to increase fluids after the test to flush the contrast from your system.
(Heart patients should consult with their physician concerning fluid intake.)
You will be required to have a blood test for creatinine to check your kidney function prior to the administration of any IV
contrast agents. If you are a woman of childbearing potential, you will need to take a pregnancy test within 24 hours of the
CT scan.
Oral contrast agents: You may be given the equivalent of 36 ounces of barium to drink over a 45 minutes to an hour
prior to your exam.
Diabetic patients
If you are diabetic and taking Metform you will have to refrain from taking Metformin for 48 hours after you have the IV
contrast agent.
Cardiac studies
You must refrain from having any caffeine for 24 hours prior to your exam.
Incidental Findings
Text (a) CT, CACTIS preferred language
Risks: CT Imaging and Incidental Findings
It is possible that during the course of the research study, the research staff (and/or radiologist that reviews your CT scan)
may notice an unexpected finding (s). Should this occur, the finding (s) will be considered by the appropriate medical
personnel and the study principal investigator will inform you if necessary. These finding(s) may or may not be significant,
and may lead to further testing (such as additional imaging studies, or biopsy). This may result in anxiety or harm to you
caused by the additional testing. The costs of such additional testing will not be covered as part of this research study.
Text (b) Incidental Findings for multiple imaging modalities, use when multiple imaging modalities are required
are used (CT, MRI, PET, US, X-ray, etc.). CACTIS accepts either version.
It is possible that during the course of the research study, the research staff may notice an unexpected finding(s). Should
this occur, the finding(s) will be considered by the appropriate personnel and the PI will inform you if necessary? These
possible finding(s) may or may not be significant and may lead to anxiety about your condition and to further work-up by
your physician.
Does your study include pregnant women?
Yes
No
If no: Pregnancy Clause--Although there are no known risks related to MRI on pregnant women or a fetus, there is a
possibility of yet undiscovered pregnancy related risks. Since there is no possible benefit from participating in this protocol
for a pregnant woman, we will exclude pregnant women. A negative urine pregnancy test will be required before a woman
of child-bearing potential can participate in this study.
If yes: Study teams should upload justification, into application, for including pregnant women in the study.
Does your CT scan require the use of Contrast Agents?
Yes
No
If yes:
Risk of IV Placement: There is a risk that multiple needle sticks will be necessary to ensure proper intravenous line
placement. There may be a small amount of pain or bruising with the placement of the intravenous catheter (IV) and a
small risk of infection at the injection site.
Risk of IV contrast agents used in CT imaging:
Most CT contrast reactions (approximately 95%) are mild to moderate in degree and most resolve themselves without
treatment. However, life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred. People with
heart disease, kidney disease or allergies are more likely to have a more severe reaction to contrast agents. If you have a
history of heart disease, kidney disease, or allergies please inform the study staff.
Common effects of iodinated IV contrast agents are feelings of overall warmth, especially in the bladder area after
injection. A metallic taste during the injection, warmth, burning sensation or momentary pain during the contrast injection
at the injection site can occur. Less common are nausea, vomiting, headache, hives and itching. Rare, but serious
reactions are rapid heartbeat, changes in blood pressure, heart attack, kidney failure, pulmonary edema, serious life
threatening allergic reaction. (* This paragraph may be substituted for the table below)
Risks of CT intravenous contrast reactions
Likely
Less likely
Rare, but serious
1. Feelings of overall warmth especially in the
bladder area after injection
4. Nausea, vomiting
7. Tachycardia, hypotension, hypertension
2. A metallic taste during the injection
5. Headache
8. Heart attack, kidney failure, pulmonary
edema
3. Warmth, burning sensation, or momentary
pain during the contrast injection at the
injection site can occur
6. Hives and itching
9. Serious life threatening allergic reaction