Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT

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University of Cincinnati

Status

Active, not recruiting

Conditions

PET/CT Imaging

Treatments

Diagnostic Test: PET/CT scan with 13 mCi radiation dose
Diagnostic Test: PET/CT scan with 2.5 mCi radiation dose
Diagnostic Test: PET/CT Scan with not yet determined radiation dose
Diagnostic Test: PET/CT Scan with 6.5 mCi radiation dose
Diagnostic Test: PET/CT scan with 5 mCi radiation dose

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03519659
R01CA195513 (U.S. NIH Grant/Contract)
RP0308/2014H0437

Details and patient eligibility

About

The purpose of this study is to assess new low radiation dose techniques for clinical PET/CT scans through intra-individual comparison between a clinical, standard dose scan and a low-dose scan, completed within one week of each other.

Full description

Positron Emission Tomography/Computed Tomography (PET/CT) imaging using 18F-FDG is an important, commonly used cancer, neuroscience and cardio-vascular imaging methodology to detect disease and to monitor therapeutic interventions. While considerable technological progress of PET/CT systems has occurred over the last decade, we have not re-evaluated the ability to potentially reduce the radiation burden of the used PET imaging pharmaceutical (FDG). This early phase trial intends to accomplish the following: to validate that the radiation dose burden from the PET imaging pharmaceutical (FDG) can be reduced by more than 50% from the current standard of clinical care (SOC) level without affecting the diagnostic ability; to confirm that a low dose approach will be feasible for response assessment; to validate that the difference in FDG uptake between imaging 60 min +/- 10 min post injection and 75 min +/- 10 min post injection is independent/equivalent of the injected FDG dose to validate a simulation methodology to streamline future dose finding studies for PET imaging pharmaceuticals.

Enrollment

190 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male and female patients greater than or equal to 18 years of age
  • Patients scheduled for a standard of care PET/CT scan
  • For female patients of child-bearing potential, the OSUWMC requirements for receiving the standard of care PET imaging agent and CT examination needs to be met

Exclusion criteria

  • Participants who are pregnant or lactating
  • Prisoners
  • Participants incapable of giving informed consent
  • Patients unable to lie flat on the scanner for extended periods of time

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

190 participants in 6 patient groups

Sub-Study A
Experimental group
Description:
Patients receive PET/CT scan on Gemini Astonish PET/CT
Treatment:
Diagnostic Test: PET/CT scan with 5 mCi radiation dose
Diagnostic Test: PET/CT scan with 13 mCi radiation dose
Sub-Study B
Experimental group
Description:
Patients receive PET/CT scan on Biograph mCT
Treatment:
Diagnostic Test: PET/CT scan with 5 mCi radiation dose
Diagnostic Test: PET/CT scan with 13 mCi radiation dose
Sub-Study C
Experimental group
Description:
Patients receive PET/CT scan on Discovery PET/CT
Treatment:
Diagnostic Test: PET/CT scan with 5 mCi radiation dose
Diagnostic Test: PET/CT scan with 13 mCi radiation dose
Sub-Study D
Experimental group
Description:
Patients receive PET/CT scan on Vereos 128 digital PET/CT
Treatment:
Diagnostic Test: PET/CT scan with 5 mCi radiation dose
Diagnostic Test: PET/CT scan with 13 mCi radiation dose
Sub-Study E
Experimental group
Description:
Patients receive lower radiation dose on Vereos 128 digital PET/CT
Treatment:
Diagnostic Test: PET/CT Scan with 6.5 mCi radiation dose
Diagnostic Test: PET/CT scan with 2.5 mCi radiation dose
Sub-Study F
Experimental group
Description:
Patients receive PET/SCAN using system that did not show equivalence in Sub-Study A-C
Treatment:
Diagnostic Test: PET/CT Scan with not yet determined radiation dose
Diagnostic Test: PET/CT scan with 13 mCi radiation dose

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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