Intra-individual Comparison of Conventional and Digital PET/CT Scanners

September 18, 2019 updated by: Piet Jager, Isala

Intra-individual Patient-based Comparison of Conventional and Digital PET/CT Scanners

In this study, the investigators will analyze the impact of digital PET/CT on the final diagnostic conclusion of the scan in patients with lung cancer, breast cancer, esophageal cancer and a group of mescellaneous cancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There will be a single injection of the PET radiopharmaceutical FDG, followed by a conventional PET/CT scan and a digital PET scan, in this order or vice versa.

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025AB
        • Isala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  • referred to Isala for a clinically indicated FDG-PET/CT scan
  • suspected or proven lung cancer, esophageal cancer, breast cancer or miscellaneous cancer, either as a primary diagnosis or follow-up study
  • signed informed consent

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  • age < 18 years
  • incapacitated adults
  • prisoners
  • pregnant patients
  • unable to undergo two consecutive PET/CT scans

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients undergo a digital PET/CT
Single arm prospective study of paired PET scans. Patients who are referred to the nuclear medicine department to undergo a PET scan, will undergo a PET/CT scan on the conventional scanner as well as the digital PET/CT scanner.
Diagnostic test: Digital PET/CT scan
The digital PET/CT scan will be acquired before or after the conventional PET/CT scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic outcome of the PET/CT study
Time Frame: approximately 2 hours
approximately 2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
PET image quality
Time Frame: approximately 2 hours
approximately 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isala

Collaborators

Philips Healthcare

Investigators

  • Principal Investigator: Pieter L Jager, MD PhD, p.l.jager@isala.nl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

September 13, 2019

Study Completion (Actual)

September 13, 2019

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NL52329.075.15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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