PET: Steps to Start a Clinical Research (Human Subject) PET Study

Steps needed to start a new study that involves use of a radioactive agent

(PET radiotracer-commercially sourced FDA-approved NDA radiotracer/IND radiotracer/RDRC radiotracer)

 

Submit a UPMC PET Facility Resource Availability Agreement

http://www.rad.pitt.edu/pet-service-agreement.html

 

Information needed:

  • Title of Protocol
  • Principal Investigator
  • Funding Source
  • Start date
  • End date
  • Number of scan sessions
  • Name of Radiotracer(s)

If you have questions regarding this process, contact James Ruszkiewicz at 412.647.0712 (ruszja@upmc.edu).

 

Agreement needs to be signed by the Director of the PET Facility, Radiology Departmental Fiscal Administrator, and the Principal Investigator.

NOTE: This agreement should not be uploaded in PittPro, this is an internal PET Facility document for budgeting purposes only.

 

Please note that the cost(s) outlined in the PET Facility Resource Availability Agreement is for the cost(s) associated only with the PET scan portion of a study protocol. If the proposed study utilizes MR Research Center (MRRC) resources (including the mMR), the PI must obtain cost(s) associated with any MRRC activities. Please contact the MRRC (Jennifer Dobberstein [dobbersteinj@pitt.edu]) to obtain those costs.

 

When creating the IRB study submission in PittPRO, list James Ruszkiewicz as “Key Personnel”

 

In the Drug section of PittPro check Yes for Q2 - Will the study be conducted under an investigational new drug application (IND) and/or require review by the Human Use Subcommittee (HUSC) of the University of Pittsburgh Radiation Safety Committee?

 

James Ruszkiewicz will complete the required HUSC-RSC Form 1001. This is the Human Use Subcommittee/Radioactive Drug Research Committee Application for the Research Use of Ionizing Radiation. He will also create a dose table corresponding to the study protocol. The following information will be required to complete the HUSC-RSC Form 1001:

  • Title of Protocol
  • Age Range of participants - (Note that subjects under the age of 18 require special review considerations and lower dosimetry limits compared to adults)
  • Number of Research Subjects that will receive radioactive agent as part of protocol
  • Number of Normal Volunteers that will receive radioactive agent as part of protocol
  • Which research camera will be used? (mMR, HR+ or mCT) (or location of imaging site if study to be conducted on a camera other than one operated by the University of Pittsburgh PET Facility.

 

Once complete, the HUSC-RSC Form 1001 will need to be signed by signed by Dr. James Mountz (Authorized User).

 

James Ruszkiewicz will create a PDF of the HUSC-RSC Form 1001 that the PI will need to sign.

 

Completed and signed HUSC-RSC Form 1001 should be up-loaded to PittPRO (Local Supporting Documents Section).

 

The RDRC is required by FDA regulation to meet as a full-committee to review applicable radioactive drug studies. The RDRC and HUSC meet once a month (the third Wednesday of each month to review materials submitted on or before the deadline date for that month).

 

IMPORTANT:

Research protocols qualifying for formal review by the convened RDRC and/or HUSC must be submitted in PittPRO and available for review by 5 p.m. on the second Tuesday of each month in order to permit their review at that month’s RDRC and/or HUSC meetings.