Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:35 PM
Study NCT ID:
NCT01701167
Status:
UNKNOWN
Last Update Posted:
2012-10-04
First Post:
2012-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Verification of the Quantitative Accuracy of the PET/CT System Imaging Chain
Sponsor:
Toshiba America Medical Systems, Inc.
Organization:
Study Overview
Official Title:
ROMAN (PCA-9000A) PET/CT System Verification
Status:
UNKNOWN
Status Verified Date:
2012-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study will evaluate new technologies that have been included in the new PCA-9000A PET/CT System.
Detailed Description:
Scope:
To evaluate the new technologies that have been included in the PCA-9000A PET/CT System, the study has the following 3 goals.
* Define and confirm all supported clinical protocols from Low-Dose CT, to PET acquisition and presentation.
* Verification of the quantitative accuracy of the imaging chain.
* Evaluate the performance and stability of the new system and its related quality control and calibration procedures.
Result (Expected):
The study is an essential step in assessing the quality of the hardware and software defining the new PCA-9000A PET/CT System. Several essential parameters for the acquisition, reconstruction, correction, filtering, and presentation will be estimated or adjusted during this period. The evaluation will confirm PCA-9000A PET/CT System is effective for its intended use.
To evaluate the new technologies that have been included in the PCA-9000A PET/CT System, the study has the following 3 goals.
* Define and confirm all supported clinical protocols from Low-Dose CT, to PET acquisition and presentation.
* Verification of the quantitative accuracy of the imaging chain.
* Evaluate the performance and stability of the new system and its related quality control and calibration procedures.
Result (Expected):
The study is an essential step in assessing the quality of the hardware and software defining the new PCA-9000A PET/CT System. Several essential parameters for the acquisition, reconstruction, correction, filtering, and presentation will be estimated or adjusted during this period. The evaluation will confirm PCA-9000A PET/CT System is effective for its intended use.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: