Applications of Dual-Energy Computed Tomography

Other Conditions That May Be A Focus of Clinical Attention Clinical Trial

Official title:

Applications of Dual-Energy Computed Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801514
• Other study ID #: iCT DL
• Status: Completed
• Phase: N/A
• First received: February 27, 2013
• Last updated: November 10, 2014
• Start date: November 2012
• Est. completion date: March 2014

Study information

• Verified date: November 2014
• Source: Philips Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the feasibility of multilayer detection-based dual energy computed tomography scanner and to assess the added diagnostic value of dual energy applications

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Male or female subject

2. Subjects with relative clinical findings indicative for CT examination. CT referral request approved by a physician is needed

3. Voluntary signed the Informed Consent Form

Exclusion Criteria:

1. Pregnant or potentially pregnant female subjects

2. Subjects who are not able or not willing to give written Informed Consent without a caregiver consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Other Conditions That May Be A Focus of Clinical Attention

Intervention

Device:
• Computed Tomography scan
Routine Computed Tomography scan

Locations

Country	Name	City	State
Israel	Hadassah-Hebrew University Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Philips Healthcare

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capability of producing dual energy computed tomography imaging and dual energy applications		6 months	No