NCT03387618

Brief Summary

The purpose of this study is to assess the feasibility of investigational Positron Emission Tomography (PET) imaging using the new generation digital detector PET technology for new procedures beyond the current standard of care.

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
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

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

September 19, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
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

7.3 years

First QC Date

November 20, 2017

Last Update Submit

January 16, 2024

Conditions

New-generation Digital PET/CT Imaging

Outcome Measures

Primary Outcomes (2)

  • Image Quality

    Assessing the benefit of the new advanced PET technology to improve the capabilities of PET imaging

    through study completion, an average of 3 years

  • Accelerated Acquisition Time

    The necessary time of the patient to be on the imaging system table/bed will be measured and reported. Currently, the common acquisition time is approximately 20 minutes. We explore to reduce imaging times to 5 or 10 minutes.

    through study completion, an average of 3 years

Study Arms (1)

Investigational Scan

EXPERIMENTAL

new-generation digital PET/CT imaging technology

Diagnostic Test: Digital PET/CT imaging

Interventions

Digital PET/CT imagingDIAGNOSTIC_TEST

Next generation PET/CT imaging

Investigational Scan

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 having a medical diagnosis which justifies exploratory PET imaging

You may not qualify if:

  • Participants who are pregnant or lactating
  • Prisoners
  • Subjects incapable of giving informed written consent or who are unlikely to complete the imaging procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martha Morehouse Medical Plaza

Columbus, Ohio, 43221, United States

Location

Study Design

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

Study Record Dates

First Submitted

November 20, 2017

First Posted

January 2, 2018

Study Start

September 19, 2017

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations

US(1)