Authorization for performing studies in categories 2, 3 and 4 must be obtained from the CACTIS center.
A monitoring plan must be submitted for all NIH/NCA studies. For all category 4 uses (clinical trials) an external monitor must be part of the monitoring plan (this may include monitoring by the Cancer Center, etc.).
All CACTIS approved protocols must re-submit yearly.
The CACTIS expiration date is the same as the IRB expiration date. Example: IRB expiration: 12/1/22 (your study also expires for CACTIS on this date)
For all categories 2, 3 and 4, a CT technologist must be used to ensure that all of the screening and safety procedures involved in conventional clinical CT scanning are followed. Each request should designate a board certified radiologist within the HUP Radiology department as the "contact person" for the study. A licensed physician with training in recognition and treatment of contrast reactions should be in the CT facility when the study is being performed. This need not be a member of the study team.
All research groups using the center for studies on humans will have at least one member of the group trained in Cardiopulmonary Resuscitation (CPR) and present during scanner sessions. The scanning technologist is considered part of the group. The CPR certification should be renewed annually. This policy is to allow skilled delivery of emergency care while the hospital code team is en route. Courses are given regularly here at the hospital and elsewhere.
Radiology Reports
Formal reports are not provided for most research CT’s unless a Radiologist is listed on the project as a sub-investigator who will take responsibility for the interpretation and dictation of a report. If during a research study an unexpected abnormality is incidentally observed during the CT part of the examination, the investigator should inform the "contact" Radiologist. The Radiologist should review the results and advise the investigator on a course of action. This report should be formally documented in the medical record.
Reader services are available for neuro, body, chest and cardiovascular CT studies. Investigators can either invite a radiologist to participate as a member of the study team or request a reading on a per case basis.
The fee for reading a neuro, chest or cardiovascular CT study is $55.00.
The fee for body imaging is $100.00 per evaluation. Reader services are only for exams that do not require any special measurements or evaluations.
Radiologist Responsibility
CACTIS requires that all research protocols that require special evaluation using our service center must include a radiologist on their study team. The radiologists' responsibility is to ensure that the proper CT procedure is performed and evaluated according to the protocol’s specifications. The radiologist will also review images for incidental findings and notify the PI in such a case. Reports as specified above are not routinely generated through CACTIS, however, arrangements can be made with the study radiologist to provide exam reports.
Security Issues
All groups are responsible for maintaining security and restricting unwarranted access to the facility and subject health data. This includes basic safety in the scanner area during use and securing the facility when not in use. If a problem arises with an unauthorized person or persons, scanning should stop and hospital security notified.
Safety Issues
Non-FDA approved devices can only be used following designation as non-significant risk by the IRB and approval by CACTIS. There must be reference in the protocol and consent forms to non-significant risk investigational devices. Devices and sequences to be used for applications which exceed the FDA's guidelines must be under an IDE from the FDA as well as having approval from the IRB and CACTIS.
Human Venipuncture / injection can only be performed by RN’s, PA’s, MD’s and others credentialed by the hospital for these procedures.
All CT imaging protocols utilizing one of our in-stock and pre-approved IV contrast agents must send a prescription for the contrast for each subject who will be scanned. The MD prescribing the contrast agent must be the Investigator, a co-investigator or a sub-investigator. All research subjects must be screened for possible contrast allergies, pregnancy and contraindications before the scanning procedure is scheduled.
Investigator Responsibility
All research volunteers must be pre-screened prior to scheduling. CACTIS has designed a screening form that is available on the website. If you have any questions regarding patient screening, please contact the participating radiologist.
Although research volunteers will be scanned in the same area as clinical patients, they must be accompanied by a study team member for their own safety. It is the principal investigator’s responsibility to ensure that every subject is escorted to CT. The team member MUST accompany their subjects to the CT section, notify the technologist of the research procedure to be performed, complete all screening paperwork with the subject and answer all questions prior to their departure. Coordinators (or team members) are not required to remain with the study patients who are scheduled for non-contrast procedures. For subjects who are receiving IV contrast, a study team member MUST be present throughout the exam to record data such as contrast administration, injection information, and contrast related adverse events. The team member, not the CT staff, is responsible for pre and post monitoring. Contrast reactions can often be delayed. CACTIS recommends at least a 30-minute observation period post procedure for subjects who receive IV contrast. Research volunteers who come to the department unaccompanied will not be scanned until a team member is present. This is a departmental policy and is strictly enforced by the CACTIS committee.
The investigator is responsible for obtaining all pre-study data about the scanners and department protocols. Please contact Andrew Koch, lead CT Technologist, for assistance.
The charge for protocol qualifying procedure scans is $150.00.
The investigator or team member must supply the CT technologists with training in filling out forms, patient data entry (patient ID vs. name) and custom protocols prior to study start. The investigator must contact Andrew Koch to set up a training session before the first patient is scheduled. Proof of training will be required before the first subject is scheduled for all complicated CT protocols.
Data Analysis
Describe the investigator's plan to analyze the data such that a conclusion can be drawn. CACTIS looks for no specific details, but a plan for statistical analysis of the data to correlate with the purpose of the study and/or experiment involving human subjects. For small studies of limited risk, a short description of the analysis plan is sufficient.
Pregnancy issues
Although CT scans are regulated and monitored to provide the lowest possible radiation dose, there is always the possibility of side effects on pregnant women or the fetus. All female participants must be properly informed of these risks both verbally and in written form. All studies involving ionizing radiation are required to provide a pregnancy clause in the informed consent form. Women who participate in CT for research purposes are required to have a negative pregnancy test or one of the following: s/p menopause, s/p hysterectomy, or s/p tubal ligation. Type of birth control used or abstinence must be documented in the study records.
Criteria for "women of child bearing potential" guidelines: to exclude or not to exclude from "mandatory" pregnancy tests to clarify any misinterpretations. Applies to all females of child bearing potential from the ages of 10 and up. Note: pregnancy test must be done within 24 hours prior to the CT to be considered acceptable.
Unless your protocol and consent specifically states that only post-menopausal women or women s/p hysterectomies will be eligible to participate or that all women of child bearing potential are to be excluded (inclusions/exclusions), a pregnancy statement must be included.
Risk-Benefit Ratio
The risk benefit ratio as well as all portions explaining risk or patient safety will be reviewed by the center. The main reason for this is to ensure patient radiation exposure is kept to a minimum. CACTIS will work closely with the radiation safety committee in reviewing all protocols, especially those using "non-standard" parameters for scanning. You can find more information about their protocol submission process at EHRS's website: www.ehrs.upenn.edu
Informed Consent Information
The following paragraphs should be added to all consent forms that will be using CT imaging.
CT Standard Language: 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.
CT Imaging 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.