NCT06510036

Brief Summary

Patients who visited our hospital for various reasons from January 2024, underwent CT scans involving the pancreas, and were eligible for spectral post-processing reconstruction were included in the study. This research collected spectral CT data related to the pancreas at different phases, as well as physiological and pathological states for these patients. Quantitative analysis was conducted on post-processed data under different physiological and pathological states, including parameters such as pancreatic iodine uptake features, attenuation interval slopes, and extracellular volume size. In conjunction with general patient status, biochemical tests, and postoperative pathological results, the study aimed to identify correlations between parameters, develop models, and conduct research by comparing traditional CT data, which could be matched with spectral CT from the PACS database since its establishment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Jan 2021Jun 2028

Study Start

First participant enrolled

January 21, 2021

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2028

Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

6.4 years

First QC Date

June 12, 2024

Last Update Submit

December 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • spectral imaging data(SBI)

    Using Philips Intellispace Portal software to reconstruct spectral imaging data images

    21/3/2025

  • ROI area(mm2)

    Using Philips Intellispace Portal software to delineate the Region of Interest (ROI)

    21/3/2025

Secondary Outcomes (1)

  • single-energy CT value

    21/3/2025

Study Arms (2)

test group

Post processing patient data using energy spectrum CT

Other: The post-processing generated after scanning is converted into energy spectrum image data (SBI)

control group

Collect traditional CT data that can correspond to spectral CT since the establishment of PACS database to form a comparison

Other: The post-processing generated after scanning is converted into energy spectrum image data (SBI)

Interventions

It will not open special sequences for patients, will not increase the cost of diagnosis and treatment, will not increase radiation exposure during enhanced CT scanning, and will not affect the normal diagnosis and treatment process of patients throughout the process.

control grouptest group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Age, sex, body mass index (BMI) and grading, diabetes history, smoking history, hypertension. Patients with primary pancreatic disease who undergo surgery or biopsy according to clinical routine during their hospitalization in our hospital and obtain pathological results are included.

You may qualify if:

  • Since March 2024, I have been visiting our hospital for various reasons and have undergone CT scans involving the pancreas (using energy spectrum CT)

You may not qualify if:

  • Previous pancreatic surgery with incomplete pancreatic tissue.
  • Severe systemic diseases that result in severe organ dysfunction
  • Excessive pancreatic atrophy or other reasons cannot accurately delineate ROI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Central Study Contacts

Yu Shi, doctor

CONTACT

Liuhanxu Shen, undergraduate degree

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 12, 2024

First Posted

July 19, 2024

Study Start

January 21, 2021

Primary Completion (Estimated)

June 21, 2027

Study Completion (Estimated)

June 21, 2028

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations