Radiologists, physicists, and technologists help researchers utilize the resources available within the Department of Radiology at the University of Pennsylvania. Our mission is to oversee proposed research protocols that involve human, animal, phantom or specimen studies in an effort to achieve two goals:
• To ensure that all research performed on the CT scanners comply with CACTIS and University policy, and Federal Regulations
• To determine if CACTIS can maintain the resources required to carry out each research protocol, including personnel, software, hardware and scan time
Under the direction of the Chair, Dr. Harold Litt, the CACTIS committee reviews proposed research requests and makes decisions and recommendations accordingly.
• Oversees the day-to-day operations of all CT procedures associated with research protocols
• Provides information regarding the use of the CT facilities to the research community at the University of Pennsylvania
• Provides CACTIS users with all of the policies of the institution governing research
• Ensures that CACTIS is in compliance with these policies
Role: Clinical Research Coordinator
"Protocol development (PRODEV) accounts are available to investigators who need preliminary data for future grant submission. The radiology department grants protocol development funds for this purpose.
Investigators must apply to the protocol development committee and gain approval for funding before a study will be reviewed by CACTIS. To apply for protocol development funds, contact Kathleen Thomas, Clinical Research Operations Manager.
Once protocol development funds are approved, investigators may submit the appropriate CACTIS application for CACTIS review."
The CACTIS Coordinator guides study coordinators and PIs through the approval process and establishes appropriate CACTIS and Image Anonymization accounts (IAAR). CACTIS accounts are required for research studies that use the CACTIS research scanner.
"All individuals operating within the CT environment will be trained, registered radiologic technologists, radiologists or approved users and must have reviewed procedural standards of safety, preparation, and clean up set forth in this SOP.
Unless an individual has been given user approval status through CACTIS, all animal studies must have a registered CT technologist or radiologist present to operate the CT scanner and to assure decontamination procedures are followed."
"Review the CACTIS Center policies and procedures regarding human clinical studies.
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: 12/1/16 (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."
"Technical development projects are intended to allow researchers to use abandoned time on the CT scanner (at no charge) to develop and/or test new CT protocols, contrast agents or CT-related equipment.
Due to the radiation exposure incurred with CT scans, only animals, phantoms or specimens may be scanned for this type of research.
In most cases, a CT technologist will be required to operate the CT scanner and technical time is only made available when a technologist is available. All animal studies require a technologist or radiologist to operate the CT scanner.
Investigators using the scanner for specimen or phantom studies, without a CT technologist, must provide a copy of their certificate of operation in fluoroscopy. The CACTIS staff will maintain these certificates."
For those studies that do not need to use the CACTIS research scanner, but do need CT images de-identified and saved to a CD, CACTIS offers a separate service called the Image Anonymization Account Request (IAAR) that can be set up for this purpose.