Spectral CT Clinical Trial

• Sponsor: Philips (China) Investment CO., LTD (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05361356
• Collaborator: (none)
• Enrollment: 86
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 3.7
• Patients Per Site: 28.7
• Patients Per Site Per Month: 7.8

Study Details

Study Description

Brief Summary

The objective of this clinical trial was to evaluate the efficacy, ease of operation, stability, and safety of Spectral CT as expected.

Condition or Disease	Intervention/Treatment	Phase
Adult ALL	Radiation: Spectral CT scanning	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 86 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Spectral CT Clinical Trial
• Actual Study Start Date: Mar 10, 2022
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group, all volunteer will be scanned.	Radiation: Spectral CT scanning; Volunteer accept spectral CT scanning

Outcome Measures

Primary Outcome Measures

1. Excellent and good rate of clinical imaging [Up to 12months]

   Perform the image quality assessment, the score 4 and 5 the total rate

Secondary Outcome Measures

1. Safety event rate [Up to 12months]

   Collect the AE and SAE occurred in the course of clinical trial execution

2. Operational satisfaction [Up to 12months]

   use questionnaire to assess the operational satisfaction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Volunteers (ages 18 to 75);

• Negative pregnancy tests for women of childbearing age;

• Agree to participate in the clinical trial and sign the subject informed consent form;

• Enhanced scan requires laboratory evidence of normal renal function.

Exclusion Criteria:

• The body cannot comply with CT examination;

• Pregnant and lactating women;

• Claustrophobia;

• People who are not suitable for enhanced scanning with iodine contrast agent (previous severe heart failure and hyperthyroidism, iodine contrast agent allergy and susceptibility);

• Patients deemed unsuitable for participation in this clinical trial by the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing		China
2	Nanfang Hospital	Guangzhou		China
3	The First Hospital of Xian Jiaotong University	Xi'an		China

Sponsors and Collaborators

• Philips (China) Investment CO., LTD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philips (China) Investment CO., LTD
• ClinicalTrials.gov Identifier: NCT05361356
• Other Study ID Numbers: PD_CT_Hawk_2021_11257
• First Posted: May 4, 2022
• Last Update Posted: May 4, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Philips (China) Investment CO., LTD: CT scanning, image assessment

Study Results

No Results Posted as of May 4, 2022