Nuclear Medicine Imaging for Research Form

NUCLEAR MEDICINE IMAGING FOR RESEARCH FORM

This form is your communication with the HIRE committee. Errors and/or omissions could result in significant delay of approved consent language. Allow a minimum of 2 weeks processing time for your trial.

Please Note: Do not add personnel from outside of UVA to the form. This form is to be completed by UVA study team members and is to indicate contact information for members within the UVA System.
IRB-HSR Submission #*
Sponsor Protocol #*
Sponsor*
Principal Investigator*
UVA Study Contact*
UVA Study Contact Email*
Study Coordinator (if different from UVA Study Contact listed above)
Study Coordinator Contact Email
Title of Study*
Modalities/ Procedures used for Research*
Do NOT check if being done for clinical care. For studies involving multiple types of nuclear medicine scans, fill out a separate form for each.
- Nuclear Medicine Imaging
- Off-Label or Non-FDA Approved Imaging
Nuclear Medicine Imaging
Please Note: If using off-label or non-FDA approved imaging, please select the "Off-Label..." button above.
Is the radiopharmaceutical FDA approved for intended use?
- Yes
- No
If you answered No, go back and check the box for Off-Label or Non-FDA Approved Imaging in the question above.
Indicate radiopharmaceutical being used

e.g. 99mTc- Sestamibi
Scan Type

e.g. MUGA, Bone Scan
Scan 1
Rest and Stress scans are considered 2 separate scans. MUGA scans typically use 30 mCi/scan. Not all procedures will have multiple scan protocols - leave "Scan 2" blank for these types of procedures. Enter N/A for number of scans if end point not known and indicate the frequency in the box below.
Number of Scans: Scan 1
Injected Activity: Scan 1
Scan 2
Not all procedures will have multiple scan protocols - leave this question blank for these types of procedures. Enter N/A for number of scans if end point not known and indicate the frequency in the box below.
Number of Scans: Scan 2
Injected Activity: Scan 2
Frequency or time points that these scans will be performed for research
Leave blank if total number is indicated above
Is this a PET/CT imaging study?
- Yes
- No
A CT scan is performed with ALL PET scans
If yes, indicate the anatomy being imaged w/ CT

e.g. abdomen, head, whole body
Off-Label or Non-FDA Approved Imaging
Indicate radiopharmaceutical being used:
IND #:
Scan 1
Not all procedures will have multiple scan protocols - leave "Scan 2" blank for these types of procedures. Enter N/A for number of scans if end point not known and indicate the frequency in the box below.
Number of Scans: Scan 1
Injected Activity: Scan 1
Scan 2
Not all procedures will have multiple scan protocols - leave this question blank for these types of procedures. Enter N/A for number of scans if end point not known and indicate the frequency in the box below.
Number of Scans: Scan 2
Injected Activity: Scan 2
Frequency or time points that these scans will be performed for research
Leave blank if total number is indicated above
Is this a PET/CT imaging study?
- Yes
- No
A CT scan is performed with ALL PET scans
If yes, indicate the anatomy being imaged w/ CT

e.g. abdomen, head, whole body
For questions regarding Nuclear Medicine Procedures, contact Alfredo Lopez at x49364
Additional Comments
If the trial does not have a clear end point, please specify what determines end of treatment. Also comment on what additional X-ray and/or Nuclear Medicine based scans subjects will receive as standard of care.
Supporting Documents
Drop files here or

Max. file size: 29 MB.
The majority of trials do NOT need supporting documents if the imaging for research purposes is simple. However, if your trial is sufficiently complicated, or you simply want us to have your protocol or other supporting documentation for clarity, upload those documents below.
*
- The PI has considered alternatives to ionizing radiation imaging where possible and has worked to maximize the benefit/risk ratio when using any Nuclear Medicine imaging. Please note - this form is your communication with the HIRE committee. Errors and/or omissions could result in significant delay of approved consent language.
PI initials typed*

Nuclear Medicine Imaging for Research Form

NUCLEAR MEDICINE IMAGING FOR RESEARCH FORM

Please Note: Do not add personnel from outside of UVA to the form. This form is to be completed by UVA study team members and is to indicate contact information for members within the UVA System.

Nuclear Medicine Imaging

Scan 1

Scan 2

Off-Label or Non-FDA Approved Imaging

Scan 1

Scan 2