Download Specifications and Instructions

Chapter: Clinical Trials
No. CLP1000501
Subject: ImpACT-24 Imaging Protocol for implantation
Rev.: A
Page 1 of 2
Overview:
1.
This Protocol is for CT imaging in patients enrolled for the ImpACT-24 study for
whom the screening CT performed does not comply with the navigation system
requirements.
2.
The goal of the imaging is to provide a pre-operative CT to be used during
implantation.
3.
The CT does not require contrast agent injection.
4.
The basic principle to achieve satisfactory study is spiral image acquisition to
enable all possible needed manipulations.
6.
The important acquisition parameters are listed in the table below.
Data exports:
The CT imaging data shall be exported according to the following guidelines:
1.
All DICOM files shall be burned on a CD.
2.
Patient identifier to be included:
a.
ImpACT-24 Patient ID (4-digits, used in the e-CRF)
b.
Patient's birth date
c.
CT scan date
d.
No other patient data shall be present in the DICOM files or on the CD
cover
3.
The CD shall be marked with the 4-digit patient ID.
4.
Before releasing the CD, please verify that it is readable.
5.
The CD shall be filed in the patient's file for collection by Study personnel.
Chapter: Clinical Trials
No. CLP1000501
Subject: ImpACT-24 Imaging Protocol for implantation
Rev.: A
Page 2 of 2
ImpACT-24 CT Acquisition Protocol for implantation
TITLE:
Pre-operative CT for navigation system
TECHNIQUE:
SPIRAL
ANATOMICAL BORDERS:
brain to below mandible
ACQUISITION:
Thin slices
THICKNESS:
1mm
INCREMENT:
1mm
PITCH:
0.6 (1 maximum)
MATRIX:
512
F.O.V:
300
TILT:
0°
SEGMENTATION:
Thin sliced