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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457506
• Other study ID #: NL52329.075.15
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: September 13, 2019

Study information

• Verified date: September 2019
• Source: Isala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: September 13, 2019
• Est. primary completion date: September 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Esophageal Cancer
• Lung Cancer
• Miscellaneous Neoplasm

Intervention

Diagnostic Test:
• Digital PET/CT scan
The digital PET/CT scan will be acquired before or after the conventional PET/CT scan.

Locations

Country	Name	City	State
Netherlands	Isala	Zwolle	Overijssel

Sponsors (2)

Lead Sponsor	Collaborator
Isala	Philips Healthcare

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic outcome of the PET/CT study		approximately 2 hours
Secondary	PET image quality		approximately 2 hours