NCT03519659

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

9.5 years

First QC Date

February 22, 2018

Last Update Submit

January 16, 2024

Conditions

PET/CT Imaging

Outcome Measures

Primary Outcomes (1)

  • Image quality

    assessed by blinded readers

    through study completion, on average 2-5 years

Secondary Outcomes (3)

  • Artifacts

    through study completion, on average 2-5 years

  • Lesion detectability

    through study completion, on average 2-5 years

  • Image noise

    through study completion, on average 2-5 years

Study Arms (6)

Sub-Study A

EXPERIMENTAL

Patients receive PET/CT scan on Gemini Astonish PET/CT

Diagnostic Test: PET/CT scan with 13 mCi radiation doseDiagnostic Test: PET/CT scan with 5 mCi radiation dose

Sub-Study B

EXPERIMENTAL

Patients receive PET/CT scan on Biograph mCT

Diagnostic Test: PET/CT scan with 13 mCi radiation doseDiagnostic Test: PET/CT scan with 5 mCi radiation dose

Sub-Study C

EXPERIMENTAL

Patients receive PET/CT scan on Discovery PET/CT

Diagnostic Test: PET/CT scan with 13 mCi radiation doseDiagnostic Test: PET/CT scan with 5 mCi radiation dose

Sub-Study D

EXPERIMENTAL

Patients receive PET/CT scan on Vereos 128 digital PET/CT

Diagnostic Test: PET/CT scan with 13 mCi radiation doseDiagnostic Test: PET/CT scan with 5 mCi radiation dose

Sub-Study E

EXPERIMENTAL

Patients receive lower radiation dose on Vereos 128 digital PET/CT

Diagnostic Test: PET/CT scan with 2.5 mCi radiation doseDiagnostic Test: PET/CT Scan with 6.5 mCi radiation dose

Sub-Study F

EXPERIMENTAL

Patients receive PET/SCAN using system that did not show equivalence in Sub-Study A-C

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

Interventions

PET/CT scan with 13 mCi radiation doseDIAGNOSTIC_TEST

13 mCi 18F-FDG dose

Sub-Study ASub-Study BSub-Study CSub-Study DSub-Study F
PET/CT scan with 5 mCi radiation doseDIAGNOSTIC_TEST

5 mCi 18F-FDG dose

Sub-Study ASub-Study BSub-Study CSub-Study D
PET/CT scan with 2.5 mCi radiation doseDIAGNOSTIC_TEST

2.5 mCi 18F-FDG dose

Sub-Study E
PET/CT Scan with 6.5 mCi radiation doseDIAGNOSTIC_TEST

6.5 mCi 18F-FDG dose

Sub-Study E
PET/CT Scan with not yet determined radiation doseDIAGNOSTIC_TEST

We plan for the possibility that one of the three-Sub-Studies (A-B) would not demonstrate equivalency, and we would then perform a modified protocol in which the SOC dosing is compared to a lower and higher dose than originally tested.

Sub-Study F

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Interventions

Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Michael V Knopp, MD, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2018

First Posted

May 9, 2018

Study Start

July 21, 2015

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations

US(1)