Diagnostic Comparison of PET-magnetic Resonance and PET-CT in Patients With Oncologic Diseases

Neoplasm Staging Clinical Trial

— Workflow  

Official title:

Diagnostic Comparison and Workflow Evaluation of Whole Body PET-magnetic Resonance and PET-CT With and Without Contrast Media in Patients With Oncologic Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316431
• Other study ID #: KEK-ZH-Nr. 2014-0072
• Status: Completed
• Phase: N/A
• First received: December 9, 2014
• Last updated: December 15, 2016
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow scenarios will be evaluated to create imaging protocols which are time efficient and diagnostically accurate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Male and female patients from 18-90 years

• Written informed consent

• Patients with a proven or suspected oncological disease referred for a clinically -Indicated PET/CT with of without contrast media

Exclusion Criteria:

• Pregnant or breast feeding women

• Non compliance of the patient to follow the study instructions (e.g. hearing problems, dementia)

• Inclusion in another clinical trial 30 days prior to inclusion

• Age < 30years

• Contraindication for MRI (cardiac pacemaker, certain metal implants, claustrophobia

• Known allergies to contrast CT or MRI contrast media

• Patients with an glomerular filtration rate of < 60ml/min/1.73m2

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasm Staging

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Diagnostic and Interventional Radiology	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with correct TNM staging defined with PET/magnetic resonance versus PET/CT		12 month	No
Secondary	Number of minutes needed per PET/magnetic resonance protocol compared to PET/CT		12 month	No