CAMRIS

Technical Development (TechDev)


All Human TechDev Sessions

 

The required form for scanning Human TechDev participants is:

https://is.gd/camristechdevsession

 

Every session is to be documented in this database.

 

If you need your operator number contact:

 

For 1.5T / 3T scanners:  Shannon Long at  Shannon.long@pennmedicine.upenn.edu

7T scanner:  Damodar Reddy at cdamodar@pennmedicine.upenn.edu

 

Description

New Magnetic Resonance pulse sequences and/or coils are continuously being developed. Such Technical Developments are typically phantom experiments of limited scope. Limited human scanning is allowed to further access the results of such techniques. These studies are for testing of such experimental magnetic resonance techniques at the field strength from 1.5 to 3 Tesla. Magnetic resonance imaging has established itself as a diagnostic tool in clinical medicine. Unlike other imaging modalities, subtle changes in the way the data is acquired can bring about large changes in image which provides more diagnostic power. Therefore, an active area of research is the design of new and better acquisition schemes for observing specific physiologic parameters and or anatomy. Before these acquisition schemes are tested in patient populations, they are tested in models or phantoms and then on normal volunteers. The difficult of jumping from model systems to patient populations directly is unforeseen problems with sensitivity to motion and physiologic functions. In addition, many of these acquisition schemes need to be fine tuned under conditions more similar to the actual clinical environment in which they will be used. Scanning of volunteers may be performed by CAMRIS technologists or users authorized by the facility Managers. must be healthy and at least 18 years of age, who are involved in MRI Technical development, who are knowledgeable about MRI and who have a knowledge of MRI examinations and the risks involved. These studies may take place on any of the University of Pennsylvania Radiology Departments MRI Scanners. This research protocol has been developed to design and test magnetic resonance imaging and spectroscopy techniques. This includes testing RF coils and pulse sequences that have been developed at the University of Pennsylvania. Before these techniques are tested in humans, they have been thoroughly tested on phantoms to determine both performance and safety. In addition, the radiofrequency coil is tested to ensure that its properties are such that FDA guidelines for specific absorption ratio (SAR) will not be exceeded and the specific technique and instrumentation being used will not permit the SAR or the dB/dt (rate of change of magnetic field) values set by the FDA to be exceeded. Before giving informed consent, the subjects are asked questions pertaining to metal implants, pacemakers and other possible conditions which would disqualify them from participating in this study. This process is currently being used for all MRI research studies in the hospital. Subjects will be screened for metal objects on their clothes and in their pockets and asked to remove such items. CAMRIS does not allow the scanning of Humans on the scanners without Informed Consent.

Protocol Update as of May 2016

Proper Use of the Techdev Protocol/ICF
The committee has determined that any future need for an add-on and/or modification(s) to any MRI protocol will need to go through the IRB as a Modification Submission to the Investigator’s existing IRB-approved protocol. Fortunately, the process of submitting slight changes in acquisition or procedure is quickly turned around and approved by our UPENN IRB.
We thank you for your cooperation.

 

This form is to be filled out with EACH TechDev session involving a human subject. This subject must have already enrolled in the TechDev (1.5-3T or 7T) protocol. This means they have filled out the appropriate Informed Consent (ICF). You must have both the Operator Number and the Subject Number available to fill out this form.


Although we do not consent for each session we DO SCREEN for each session.

TechDev 1.5-3T contact Shannon Long at: shannon.long@uphs.upenn.edu
TechDev 7T contact CMROI Lab, Damodar Reddy at: damodar.reddy@uphs.upenn.edu


Technical Development Protocol – FAQ’s

How do I become an “approved user” that can use the TechDev Protocol?

Approved User status is given to those individuals that have completed the following:

  1. Complete MRI Safety Training (KnowledgeLink)
  2. Complete CITI Patient Oriented Research course and HIPAA (KnowledgeLink)
  3. Complete Basic User Training (On-site training 60-90 minutes)
  4. Completion of all required paperwork
  5. Approval from individual responsible for your training (mentor)
Once I have been trained…what happens next?

Once you have completed your training and are competent to scan you will receive an OPERATOR number which is generated by CAMRIS. This number will be needed for using the actual TechDev consent and subsequent questionnaires and screening forms. If you are going to scan in the DEVON Center, you will also be issued an additional name tag to take with you when you are in the Devon facility.

How does the Protocol work?

The Operator (know your operator number) requests an Informed Consent (ICF) for the subject they wish to scan. The ICF is filled out, signed, and dated according to GCP’s. The screening and demographic forms are also filled out. The subject is assigned a subject number. If you are a subject please commit this to memory or paper as this will be your subject number for future TechDev uses. Once the ICF is completed all subsequent scans done on this particular subject will require only the screening and demographic form to be filled out. After completion of the forms the session may take place. In particular the beginning and end times of the session. NOTE: NO SESSION MAY EXCEED 90 MINUTES. Please remember there is a section of the paperwork used to document a few details of the session. You will need to know: Research Pulse sequence being tested – This sequence must be CAMRIS approved before you test it. Research Coil serial number – This can be made available to you if you don’t know it just call CAMRIS (Norman 610-888-9366)

Is “ TechDev Time” the same as the “TechDev” Protocol?

No. TechDev is abandoned free time on the scanners. This time can be taken NO EARLIER than 24 hours in advance. It can be used for phantom testing of coils or sequences. Be aware the time is volatile and can be taken back in instances of paying research and/or clinical service needs. But, the “TechDev Protocol” is usually run during TechDev time.

If I am unable to get the screening form and demographic form before the session can I scan and then fill it out later?

No, this is not in the spirit of the TechDev Protocol and if you are found to have done this you risk loss of your TechDev User status. You should make sure you have an electronic copy of the forms available to you. We can supply you with those. You may not have a copy of the ICF.

Can I have a blank copy of the Protocols “ICF”?

No, we want to make sure that only current IRB approved copies of the consent are available and signed.

Can I scan anyone that is willing to be scanned?

No, the protocol states that the only people that may participate are those that are MRI savvy and understand the risks of undergoing an MRI. You may not recruit friends and family for evaluation of conditions. Remember this is a basic “test a sequence” “test a coil” protocol. We do not anticipate this protocol being used for preliminary data for publication or any type of medical information.

Why is there a 90 minute limit on the scanning session?

This is an amount of time that was agreed upon after discussions with the IRB. 90 should be more than enough for initial evaluations of sequence and coil performance.

TechDev Time explanation

Research scanner’s schedules always have some abandoned time slots and during late hours may not have a schedule. In an effort to make these times more useful and help investigators get access to the research systems we offer TechDev time. As part of a Lab or group within Radiology you can get access to the TechDev time through the people in your lab designated as the TechDev account holders. These people are designated by the group. The people with the account have access to the CFN calendar and can sign up for abandoned slots or off hour slots. There are a few rules that govern the scheduling of the TeechDev time slots. These are:

  1. You may not sign up for a TechDev time slot more than 24 hours in advance.
  2. You must include some contact information in order to hold the slot. We must be able to let you know of last minute changes in schedule
  3. You cannot use the time without a trained operator
  4. You must relinquish your time if requested by a paying Project or Clinical service
  5. TechDev time is available only on the Research systems unless arranged through a MR Research Technologist.

All rules about the procedures to be followed during TechDev time are discussed in the Basic User Introduction training.

TechDev Users

Approved Support Personnel are individuals that have met basic safety training and have submitted a MRI completed MRI screening form. They may volunteer as a subject for the TechDev Protocol. Approved Users are those trained to operate the MRI system but may not scan human subjects. These operators can scan phantoms or animals as needed. They may not consent subjects or operate under the TechDev Protocol. They may volunteer as subjects for the protocol. Approved TechDev Users are those trained to operate the MRI system and may operate under the TechDev Protocol. They have completed CITI (POR), HIPAA, and all other CAMRIS training. They have also been taught to scan proficiently by their mentors within the UPENN MRI Research Department.

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