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

NCT03457506 | Completed

• 1 other identifier: NL52329.075.15
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Lung Cancer; Esophageal Cancer; Miscellaneous Neoplasm

Keywords

Cancer; Digital pet; Conventional pet

Outcome Measures

Primary Outcomes (1)

• Diagnostic outcome of the PET/CT study

  approximately 2 hours

Secondary Outcomes (1)

• PET image quality

  approximately 2 hours

Study Arms (1)

Patients undergo a digital PET/CT

OTHER

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

Interventions

Digital PET/CT scan DIAGNOSTIC_TEST

The digital PET/CT scan will be acquired before or after the conventional PET/CT scan.

Patients undergo a digital PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isala: lead
• Philips Healthcare: collaborator

Study Sites (1)

Isala

Zwolle, Overijssel, 8025AB, Netherlands

Location

Related Publications (1)

• Koopman D, Jager PL, Slump CH, Knollema S, van Dalen JA. SUV variability in EARL-accredited conventional and digital PET. EJNMMI Res. 2019 Dec 10;9(1):106. doi: 10.1186/s13550-019-0569-7.

  PMID: 31823097 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Esophageal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Pieter L Jager, MD PhD

  p.l.jager@isala.nl

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Model Details: All included patients will have two PET scans, one on the conventional PET (Ingenuity TF, Philips Healthcare) and one on the digital PET (Vereos, Philips Healthcare). The order of the two PET scans will differ per patient.

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: March 7, 2018
• Study Start: January 8, 2018
• Primary Completion: September 13, 2019
• Study Completion: September 13, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)