NCT03490812

Brief Summary

The goals of this study are to (1) develop and refine PET post-processing acquisition procedures, (2) generate preliminary and comparative imaging data for potential clinical trials, and (3) retrospectively evaluate standard of care PET imaging acquisitions by comparison with investigational PET imaging acquisitions.

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
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

January 2, 2015

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 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

10 years

First QC Date

February 22, 2018

Last Update Submit

January 16, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • image quality

    assessed by blinded readers

    through study completion, on average 2-5 years

  • artifacts

    assessed by blinded readers

    through study completion, on average 2-5 years

  • lesion detectability

    assessed by blinded readers

    through study completion, on average 2-5 years

  • image noise

    assessed region of interest over target tissue and background

    through study completion, on average 2-5 years

Study Arms (2)

Prospective population

EXPERIMENTAL
Diagnostic Test: PET scan

Retrospective population

EXPERIMENTAL
Other: Retrospective data analysis

Interventions

PET scanDIAGNOSTIC_TEST

Investigational PET scan as add-on to standard-of-care scan

Prospective population

Review of pre-existing data from January 1, 2001 through December 5, 2017

Retrospective population

Eligibility Criteria

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

You may qualify if:

  • Male and female volunteers greater than or equal to 18 years of age
  • Patients receiving a standard of care PET scan at OSU

You may not qualify if:

  • Participants who are pregnant or lactating
  • Prisoners
  • Subjects incapable of giving informed written consent
  • Retrospective Population:
  • Male and female patients greater than or equal to 18 years of age
  • Patients who have previously received a standard of care PET scan at OSU
  • None

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

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Michael V Knopp, MD, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON 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

April 6, 2018

Study Start

January 2, 2015

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations