Spectral CT Clinical Trial

NCT05361356 | Terminated

• 1 other identifier: PD_CT_Hawk_2021_11257
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Adult ALL

Keywords

CT scanning, image assessment

Outcome Measures

Primary Outcomes (1)

• Excellent and good rate of clinical imaging (score≥3）

  Rated items 5 points Excellent image quality for diagnostic purposes, very satisfactory 4 points good image quality, can be used for diagnosis, satisfactory 3 points Image quality defects, do not affect the diagnosis, general 2. Unsatisfactory image quality, affecting diagnosis Poor image quality, undiagnosable, unsatisfactory

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Common functions assessment

  through study completion, an average of 1 year

• Convenience evaluation assessment

  through study completion, an average of 1 year

• Machine function and stability assessment

  through study completion, an average of 1 year

• Adverse events and serious adverse events

  through study completion, an average of 1 year

Study Arms (1)

Experimental group, all volunteer will be scanned.

EXPERIMENTAL

All participation accept Spectral CT scanning; No group;

Radiation: Spectral CT scanning

Interventions

Spectral CT scanning RADIATION

Volunteer accept spectral CT scanning

Experimental group, all volunteer will be scanned.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips (China) Investment CO., LTD: lead

Study Sites (3)

Peking Union Medical College Hospital

Beijing, China

Location

Nanfang Hospital

Guangzhou, China

Location

The First Hospital of Xian Jiaotong University

Xi'an, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Daming Zhang

  Peking Union Medical College Hospital

  STUDY DIRECTOR

• Yikai Xu

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

• Ting Liu

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: May 4, 2022
• Study Start: March 10, 2022
• Primary Completion: October 19, 2022
• Study Completion: February 27, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)