NCT02316431

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

2 years

First QC Date

December 9, 2014

Last Update Submit

December 15, 2016

Conditions

Neoplasm Staging

Outcome Measures

Primary Outcomes (1)

  • Number of patients with correct TNM staging defined with PET/magnetic resonance versus PET/CT

    12 month

Secondary Outcomes (1)

  • Number of minutes needed per PET/magnetic resonance protocol compared to PET/CT

    12 month

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a proven or suspected oncological disease referred for a clinically indicated PET/CT with of without contrast media.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or breast feeding women
  • Non compliance of the patient to follow the study instructions (e.g. hearing problems, dementia)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Diagnostic and Interventional Radiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Sekine T, Delso G, Zeimpekis KG, de Galiza Barbosa F, Ter Voert EEGW, Huellner M, Veit-Haibach P. Reduction of 18F-FDG Dose in Clinical PET/MR Imaging by Using Silicon Photomultiplier Detectors. Radiology. 2018 Jan;286(1):249-259. doi: 10.1148/radiol.2017162305. Epub 2017 Sep 14.

    PMID: 28914600DERIVED

Study Officials

  • Patrick Veit-Haibach, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 12, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations

CH(1)