ACRIN PA 4002 Protocol Specific Application

ACRIN PA 4002 Protocol Specific Application

Please complete and submit the PSA in electronic format. This will expedite the application’s processing and help ensure correct information is on file.

Section I: Site Information

Site Name:

Address:

Address:

City, State, Zip code:

Section II: Personnel Information

ACRIN PA Personnel

1. ACRIN PA Principal Investigator (board certified radiologist responsible for the protocol imaging component)

Name:

Address:

Address:

City, State, Zip code:

Telephone Number:

E-mail Address: Fax Number:

Please submit the ACRIN PA Principal Investigator’s CV with the PSA (required for application review) and indicate whether the CV will be e-mailed with the application or faxed separately to the attention of ACRIN Applications at 215-717-0936.

The CV will be sent electronically with the application.

The CV will be faxed.

2. ACRIN PA Research Associate (RA who will obtain MRI data)

Name:

Address:

Address:

City, State, Zip code:

Telephone Number:

E-mail Address: Fax Number:

3. Lead MR technologist (person who will implement scan protocol)

Name:

Address:

Address:

City, State, Zip code:

Telephone Number:

E-mail Address: Fax Number:

4. Primary Medical Oncologist

Name:

Address:

Address:

City, State, Zip code:

Telephone Number:

E-mail Address: Fax Number:

5. Oncology RN/Coordinator

Name:

Address:

Address:

City, State, Zip code:

Telephone Number:

E-mail Address: Fax Number:

Note: A certificate documenting training in human subjects protection or ethics - either the NIH tutorial or your own institution’s training - is required for all personnel listed on this application (ACRIN PI, ACRIN RA, oncology staff). If needed, the NIH Web-based course is found at: http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp.

Section III: Imaging Equipment

Imaging Equipment Required for MRI

The site’s MRI scanner(s) must have the following capabilities required to perform the MRI imaging in the ACRIN PA 4002 protocol:

• 1.5T Siemens, GE, or Philips scanner
• Multi-coil torso array or other coil suitable for abdominal MRI
• Minimum gradient strength of 33 mT/m and slew rate of 120 T/m/s.

1. Does your institution have a 1.5T whole body MRI scanner with a torso phased array coil or a similar phased array coil that achieves the same results? Yes No

2. Do you have an MRI technologist who has performed dynamic contrast enhanced imaging of the liver?

Yes No

3. Do you currently use a power injector in your MRI suite? Yes No

If yes, provide the vendor and model number for each scanner that would be used for this study. The same scanner (s) must be used throughout the study at each participating site.

Scanner:Manufacturer: Model: Software Version:

Section IV: Information Systems Technology

Each participating site is required to submit MRI images to ACRIN as study data. Images can be sent either electronically via an FTP site or on a CD. Plain/hard copy films will not be accepted.

ACRIN can provide software for installation on a PC at your site that collects and submits image sets from your MRI computer or from your PACS. The images are “DICOM pushed” either from the MRI computer or from the PACS to the PC on which the software is installed. This software anonymizes, encrypts, and non-destructively compresses the images as they are transferred by FTP to the ACRIN database in Philadelphia.

The following computer requirements are required for use this software:

• Operating System Windows 2000 Pro or XP Pro
• Access to the Internet: Internet Explorer 4.0 or Netscape 4.0 higher browser
• Minimum of 50 GB available hard drive
• 512 MB RAM
• Ability to view PDF documents.

If you have a computer that meets the specifications noted above and would like the software to be installed, please indicate by checking yes and providing the contact information for the person at your site responsible to coordinate the installation:

Yes, our site would like to have software installed

Name:

Phone:

Email:

No, our site will submit MRI images on CD/media

Section V: Signatures

ACRIN Protocol Principal Investigator Confirmation

I (Name of Protocol Principal Investigator) have reviewed and agrees with the information contained in this application and approves of its review by ACRIN’s Institutional Participants Committee.

Forward your electronic PSA including the ACRIN Principal Investigator’s CV to:

ACRIN PA 4002 Page 1 of 4

Appendix: MR Image Transmission Instructions and Worksheet

I. Instructions for Image Submission

MRI Image Submission Options:

Option 1: Electronic Transfer (preferred)

Digitally generated image files in DICOM v3.0 and scanned film diagnostic images can be transmitted to the ACR Image Management Center (IMC) via FTP directly to the image archive.

Removal of Confidential Participant Information: The specific metadata elements contained in DICOM-formatted image data, which often contain information identifying the participant by name, must be removed prior to transferring the image. This can be performed using software available from ACRIN or a site-provided solution.

NOTE: When using a site-provided solution for DICOM element modification, please ensure compliance with the tables below.

Example of Removal of Confidential Participant Information: (Case number 123, Site 4202)

Tag,Subtag VR Description Schema Example

0008,0050SHAccession Number[Blank]

0010,0010PNPatient's Name[Case Number]^[Site Number]123^4202

0010,0020LOPatient ID[Case Number]123

0010,0030DAPatient's Birth Date[Do Not Modify]19500101

0010,0040CSPatient’s Sex[Do Not Modify]F

0010,1000LOOther Patient IDs[Trial ID]4002

Additional Elements That Must Be Removed Or Blank:

Tag,Subtag VR Description Tag,Subtag VR Description

0010,1001PNOther Patient Names0010,2150LOCountry Of Residence

0010,1040LOPatient's Address0010,2152LORegion Of Residence

0010,1060PNPatient's Mother's Birth Name0010,2154SHPatient's Telephone Numbers

0010,1080LOMilitary Rank0010,4000LTPatient Comments

0010,1081LOBranch Of Service0038,0300LOCurrent Patient Location

0010,1090LOMedical Record Locator0038,0400LOPatient's Institution Residence

NOTE: Any data that is not produced in a DICOM-compliant format (i.e. back projection data) must be transferred via a manual FTP submission or media. Contact ACRIN for manual FTP instructions.

Option 2: Media Transfer

In the event that either DICOM capability or transfer of scrubbed image headers is not available, images may also be sent on a CD or other digital medium for the ACRIN IMC to transfer to the image archive. Please contact ACRIN prior to sending the media to confirm compatibility.

For all questions regarding image submission, contact Timothy Welsh () 215-717-2754 or Jim Gimpel () 215-574-3238.

ACRIN PA 4002