CACTIS - Consent forms standard language for CT exams

More information about CACTIS policies and procedures can be found on the website or contact Deb Arnold at Deborah.arnold@uphs.upenn.edu.

Instructions: This text may be copied and pasted into consent forms.

What is a CT?

When to use "What is a CT scan" language

  • The subject will be getting a CT scan for research purposes and may not have had a CT scan before, the description is required.
  • Your consent form is listing a description of all the research procedures for the subject, the description is required.
  • You do not have to use the subhead "What is a CT scan" if it does not match the style of the consent form.

Example of a new subhead: Research Tests: "CT Scan"

What is a CT scan?
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 about 15 minutes or less to complete.

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Risks: CT imaging and incidental findings

When to use the incidental findings text in the consent form?

All subjects under active care at Penn Medicine must have a radiologist review the images for incidental findings even if an outside research organization is used to read the research scans. The consent form must include a clause for incidental findings if diagnostic scans are being requested for research purposes. Non-diagnostic quality scans do not need the incidental findings clause.

If only CT imaging is being used the text (a) below is preferred by the CACTIS committee, if multiple radiology imaging modalities are possible, please use text (b) for multi-modality imaging.

Text (a) CT only, 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 Clause, use when multiple imaging modalities are required for research purposes. CACTIS accepts either.

Risks: Radiology Imaging exams < list research imaging studies> and Incidental Findings
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.

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Risks: CT imaging and intravenous contrast agents

CT contrast agent: ISOVUE 370 ( non-ionic )

Risk of IV contrast agents used in CT imaging:
Most CT contrast ractions (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)

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.

* The table below may be substituted for the second paragraph above

* 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

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.

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Risks: CT imaging and ionizing radiation

Risk of pregnancy and ionizing radiation
Pregnant women will be excluded from having a CT scan due to the possibility of unforeseen side effects to the fetus. All female subjects that are capable of becoming pregnant must take a pregnancy test within 24 hours prior to the CT exam to rule out pregnancy. CT scans produce x-rays, if there is a chance of pregnancy you should inform the study staff, the CT exam should be postponed.

Risks: CT Imaging and ionizing radiation:
Please refer to the EHRS website links below for the radiation risk language for consent forms.

Radiation Safety links for consent form language.

Radiation Safety Committee; for questions contact:

William Davidson
wed@ehrs.upenn.edu
215-898-2133

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Risks: CT imaging, pregnancy and ionizing radiation

Pregnant women will be excluded from having a CT scan due to the possibility of unforeseen side effects to the fetus. All female subjects that are capable of becoming pregnant must take a pregnancy test within 24 hours prior to the CT exam to rule out pregnancy. CT scans produce x-rays, if there is a chance of pregnancy you should inform the study staff, the CT exam should be postponed.

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