CAMRIS

CAMRIS Policy and Procedures


1.5T & 3T Technical Development Protocol Policy Update (May 2016)

MRI Protocol add-on/modifications & Techdev
Investigators that request the use of a techdev protocol/ICF for an add-on and/or modification(s) to any IRB-approved MRI protocol need to submit an IRB Modification to the IRB under the Investigator’s existing protocol. The IRB can generally expedite this type of modification. 
 

CAMRIS Policy:

Use of monitoring, triggering, or ancillary devices used in the CAMRIS MRI units is limited to those that are either FDA approved for MR use or have undergone CAMRIS safety testing. At no time may any of these devices be utilized without one of these standards being in place.

To get approval/evaluation for a device needed for MRI Research please contact Norman Butler (Norman.Butler@uphs.upenn.edu) or Dr. Larry Dougherty (Larry.Dougherty@uphs.upenn.edu).

 

Pregnancy Policy

Due to possible “unknown risk” to the unborn fetus pregnant subjects are not permitted to undergo Research MR Imaging scans. Investigators should outline plans for verifying pregnancy in their Protocol. CAMRIS will NOT make pregnancy tests available for this purpose. The MRI screening questionnaire* will ask each female patient about their “pregnancy” status before each MRI session. The subject should know this status before arriving at the MRI as additional time spent on determining the status will count against the billable session.

Consistent with clinical care standards, attestation of pregnancy status will be accepted at the time of MRI screening. Existing studies that currently include pregnancy testing prior to scanning can be amended to remove the previous requirement and be submitted to the IRB for approval. Alternatively the study can be amended at the time of the next IRB continuing review. If you elect not to amend the study until the time of the next IRB continuing review, note that CAMRIS will not be supplying, performing or be responsible for any testing required in your research protocol.

 

Screening Policy

All research MRI Subjects must complete the MRI safety screening questionnaire form before taking part in the MRI session. All questions must be answered and the form reviewed by the MRI Technologist or Certified MRI Personnel. Any questions or conditional issues must be resolved prior to the MRI Session. Delays that occur because of follow-up on issues presented by answers given will be considered part of the billable session. The completed form is to be signed and dated by the MRI Technologist prior to the session.

 

CAMRIS Billing System: Log-in/Log-out & Start and End Times

The MRI session time stamp will start at the point at which the MRI suite and/or control area become committed to the scanning of the subject. The MRI session will end at the point at which Investigator’s group and subject leave the MRI suite and control area and the next client can begin. The MRI session time will include Tech time for subject assistance. This includes transporting or accompanying a subject, retrieving specific equipment that is not normally stored at the specific scanners and archiving data that causes the system to be limited in its ability to service the next scheduled client. Exceptions to the submitted start and end times are not decided by the MR Technologists. If you feel there is a discrepancy with the billing, please contact the Radiology Research Business Office, Laurie Cesaro at 215-349-8422.

 

MR Research Gad and GFR Policy

Macrocyclic agents will be used in all CAMRIS research studies requiring Gadolinium contrast based upon evidence of significantly lower Gadolinium retention from macrocyclic agents versus linear agents.

The following limited exceptions will be considered, but require review and approval by the CAMRIS scientific/safety review process prior to study approval:

  1. Protocols where the research MRI studies are performed in conjunction with clinical MR imaging procedures that use non-macrocyclic agents.
  2. Multi-center protocols specifying a non-macrocyclic agent.
  3. Strong consideration will be given to recommending against non-macrocyclic agents in the above circumstances in the absence of patient benefit-  for example,  clinical interpretation of the research study or requirement for access to a potentially beneficial treatment.

Dose and GFR

Any subject without known renal disease will not need to undergo a creatinine level. CAMRIS will accept attestation of medical history regarding absence of known renal disease.

Any subject with known renal disease of any severity undergoing administration of a contrast agent for research imaging in MRI must have a creatinine level available for the calculation of their GFR. The creatinine level must be within the last 6 months from the date of the research MRI. The most recent creatinine level must be used for the GFR calculation. ISTAT creatinine levels can be made available through arrangement with CAMRIS for a fee. Use of the ISTAT is not part of the scheduled time on MR scanner and will be in addition to the projects’ scheduled slot. Please plan accordingly. This service is charged on a per-session basis. ISTAT values can be used for subsequent scans out to the 6 month limit.

  1. All contrast imaging will be performed using the Clinical Macrocyclic Agent, unless otherwise specified and arranged through CAMRIS by the Investigator.
  2. Any change in dosing as described below must be arranged through CAMRIS.
  3. All GBCA’s administration will follow the clinical standard.
  4. Any GFR calculated below 45ml/g/m3 the Investigator must provide must a signed Gadolinium prescription from a UPENN Radiologist (situation #2,#3 below)* and the prescription must give dose and type of GBCA to be administered.
  1. Subjects with a GFR ≥ 45ml/g/m3 may receive the standard 70% dose of the Clinical Macrocyclic Agent
  2. Subjects with a GFR ≥ 30ml/g/m3 AND < and45ml/g/m3 may receive the standard 50% dose of the Clinical Macrocyclic Agent*

Subjects with a GFR < 30ml/g/m3 call and arrange directly through a Radiologist*
Pregnant subjects** cannot be administered gadolinium for research. If your protocol seeks to include pregnant subjects and administer gadolinium please contact the IRB.

 

7T Screening Standards

Due to the extremely high Magnetic field, surgical implants, medical, and work history could cause a subject to be ineligible even if that individual has had MRI’s at a lesser field strength. The following will NOT be considered safe for scanning at 7T regardless of their MR safety information 1. Any “Undefined” metallic implant or foreign bodies (FB) inside the patient/participant
2. Any life assist, bone growth, or pain management devices or instances where portions (remnants) of that life assist device remain in patients (e.g. pacer wires)
3. Any structural support devices, screws, or wires in bone that are near the spinal cord or temperature sensitive organs (e.g. Harrington rods).
4. Reconstructive metallic implants near the orbits.
5. External devices, medicinal patches, piercings, or jewelry that cannot be removed

Currently, the following will be assessed for 7T safety on a case by case basis:
1. Defined Implants other that have MR Safety information available and are listed SAFE.
2. Orthopedic and dental implants, retainers, and Braces that are secured to the teeth/bone/jaw and are not near the orbit.
3. Orthopedic implants and/or screws located in an area that will be subject to RF excitation.
4. History of foreign body to the eyes such as metal fragments (e.g. gunshot or stab wounds) or history of work/hobby involving metal work that can be cleared through radiographic means.
5. Non-metal implants (e.g. lens implants, saline implants, etc…)

Currently the following are considered a safe at 7T:
1. Dental fillings
2. Orthopedic screws, plates, or reconstructive devices that can be determined to be made of titanium and are not in the RF excitation field.

The safety considerations and discussions are:
1. Is the nature of the implant or FB magnetic? Will there be a torque or force exerted upon it could cause it to dislodge or move? The amount of torque exerted on the implant or FB will be based on the implant/FB size, the maximum gradient field the implant is exposed to and the materials making up the implant/FB
2. Will the implant/FB heat up and possibly damage surrounding tissue when exposed to the RF energy used for MR imaging. This possibility is based on many factors.
Some of these are:
     a. Size and shape of the implant/FB
     b. Position in the body. Anchoring points and perfusion surrounding the implant.
     c. Material make-up of the implant/FB
     d. Implants position with respect to the main and secondary magnetic fields.

 

Requirements for MRI studies using 7.0T and 3.0T (B100, Stellar-Chance laboratories): CMROI

Current FDA standards list imaging under the Static Field strength of 8 Tesla present “minimal risk” to subjects older than 1 month. The most common field strengths used in MRI subject scanning are 3 Tesla and below. Anything above 3T is considered Ultrahigh field MR Imaging/spectroscopy. Because of this difference the purpose of this policy is to outline specific criteria to those users wishing to scan research participants/patients within the CMROI facility. Research participants/healthy volunteers Persons with no known significant health problem can participate in the MRI research scanning procedures without the presence of a clinician or nurse.

Research patient: Any individual with a known significant health problem who is participating in a research study must be accompanied by a Clinician or healthcare professional responsible for the subjects care. REFERENCEShttp://www.fda.gov/radiation-emittingproducts/radiationemittingproductsandprocedures/medicalimaging/ucm200086.htm#lrps

 

Policy for Hair Pieces in CAMRIS MRI facility

Hair pieces such as wigs, weaves and extensions prove to be a safety issue in subjects undergoing MRI at 1.5T, 3T, and 7T. Weaves can be attached with thin filaments of wire or have a wire bead to attach to the natural hair or scalp. It is difficult to determine the exact method of how these are secured in place. In some cases these wires or small beads at the end of the wire will set off the ferrous metal detector. Wigs are often attached by small metal hooks. This may also set off the ferrous metal detectors.

Some issues that can arise while scanning these subjects are the following: a) Heating of the scalp may occur if the pieces/wigs are attached using ferrous metal fasteners, wire or clasps which can increase the risk of localized subject discomfort to potential burns. b) Artifacting--sometimes significant, can appear in the imaging which could preclude use of the data for analysis.

Policy –

a) If weave/wig has wire and/or metal bead and causes the ferrous metal detector to alarm - these subjects must remove their weave/wig to be scanned. If subject refuses to remove the weave/wig then the subject is not scanned.

b) If the weave does not set off the ferrous metal detector and the subject is placed in the scanner, but now a significant artifact is seen on the image, the subject is removed from the scanner and the scan is not completed.

c) If the subject feels discomfort during scan in area of the scalp, hair weave or wig area then the subject is removed from the scanner and the scan is not completed.

If the weave/wig does not set off the alarm on the metal detector and no artifacts or subject discomfort issues arise, then the scan will be completed.

NOTE--The above process highlights the responsibility of the study team/PI/Recruiter to ensure proper screening of their potential research recruits. If the study team recruits and attempts to scan a subject with a wig, weave or extensions then there is a risk of the scan not taking place. The cancellation of these research subjects will be final.

 

IV Line Placement

All GBCA’s are administered via Intravenous Line placement prior to entering the MRI scan room unless otherwise specified or warranted. The MRI Technologist will try no more than 3 times for I.V. access unless permitted to do so by patient and Investigator. MRI Technologists are not permitted to access ports. GBCA’s cannot be injected through a port unless specifically ordered by the radiologist. MRI Technologists are not permitted to draw blood for labs. I-STAT blood samples are done through the I.V. If you have a situation not explained or covered by this policy please contact CAMRIS.

 

CAMRIS Policy for Radiologist Involvement

Needs: There are several aspects of MRI research involving human subjects that requires radiologist oversight. This includes:

1) Need to ascertain appropriateness of imaging when potential safety concerns are identified when patients present to the MRI center

2) Availability of medical personnel to respond when safety issues arise during or immediately after MR imaging

3) Need to generate clinical reports, when appropriate

4) Need to identify an MR imaging expert when reports are not routinely obtained but possible incidental abnormalities are identified by study MRI personnel (technologists, physicists, image processing scientists).

CAMRIS offers several options to satisfy these requirements.

If clinical reads are to be performed.

Scenario A: Named radiologist to address safety and clinical reports (RES modifier)

It is often desirable to name a clinical radiologist with appropriate MRI expertise to the study as a co-investigator. The radiologist must be identifiable as an expert in the area(s) of anatomy that are scanned. Radiologists who perform this duty may require a small amount of compensation in salary effort, or may be able to provide this service without salary support based on agreement between the study PI and radiologist co-investigator (i.e. in exchange for co-authorship or other forms of recognition). CAMRIS can provide PIs with names of radiologists from the appropriate clinical sections. However, agreement for such services must be between the PI and the individual radiologist.

In such a scenario, the named radiologist and/or his/her surrogates will be responsible for aspects “1 – 4” above.

Scenario B: Utilization of the “clinical service” for safety and clinical reports (RESREPORT modifier)

In certain body parts (neuro, body) the appropriate clinical service will generate reports. In this scenario, a study radiologist need not be named as co-invesitgator on the protocol. However, election of this service requires an additional fee per imaging visit to the grant. Clinical reports will be generated and sent to the study PI (or the identified referring clinician at the time of exam scheduling if different for the study PI). It is recommended that this service be utilized only when the MRI visit utilizes a set of clinical sequences that are identical to or similar to existing clinical protocols. In such a scenario, the clinical service will be available during normal working hours to address safety issues that are identified before or after MRI scanning.

In this scenario the Radiology Section will handle aspect “1-4” . Utilization of this process places the protocol on the operational terms of the clinical service. Special exception or immediate assessment of exceptions is not available through this service. Clinical service standards will apply and cancellation of the MR sessions based on the information available will be the procedure.

If clinical reads are not to be performed (RNR modifier)

Scenario C Named radiologist to address safety issues and incidental findings

Even when no clinical report is to be generated, it is a requirement for all human MRI research studies that a radiologist be responsible for the study. This is to address safety issues that arise at the time of scanning (items 1 and 2 above), and to be available for consultative expertise if a potentially significant imaging finding (incidental finding) is identified by MRI study personnel (item 4 above). The radiologist must be identifiable as an expert in the area(s) of anatomy that are scanned. This person, or his/her designate, will accept responsibility for real time consultation with the clinical technologist for safety concerns before or during the study.

 

Policy for Scanning Minors in the CAMRIS MRI Facility

There are some protocols which require the recruitment and acquisition of MRI images on minors (those MRI research subjects between the ages of 8 and 18 years of age—CAMRIS does not scan minors under 8 years old or those that would require sedation). CAMRIS has set forth stipulations on the handling and imaging of minors within its facility. The stipulations offer increased safety measures for this vulnerable population. When a minor research MRI subject participates in a research MRI in the CAMRIS facility, the measures outlined below must be adhered to:

a. Study subject must present in the CAMRIS facility with a parent or guardian and parent/guardian must stay for the duration of the MRI research study.

b. Minor research subjects that are female that are of childbearing age (as described in the CAMRIS pregnancy policy SOP) must be cleared for pregnancy by the PI/study team prior to the research scan and outside of the CAMRIS facility due to privacy issues.

c. Once the minor research subject has entered the MRI scanning room, the parent/guardian must have visibility of the minor research subject at any time.

d. Study staff member is responsible for the minor research subject at all times upon entering the CAMRIS MRI facility, and must escort the minor research subject as well as parent/guardian out of the MRI facility upon completion of the scan.

 

PBR Billing System

There will no longer be manual corrections made to time stamps that are recorded on the PBR billing system starting September 11, 2015.

This means if you clock out past the allotted time you will be paying for that time. Starting and end times are shown to the left of the submit button.

If you need to enter text and don’t see the field ask the MR Tech for assistance.

If you forget to log out or face some other situation you MUST enter an explanation into the free text area at the bottom of the expense sheet. These entries will be reviewed and credited on merit.

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