Diagnose DiseaseNCT06510036
Assessment of Pancreatic Physiological and Pathological Characteristics Based on Spectral CT
An observational study of Diagnose Disease, run by Yu Shi at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnose Disease
- What is being tested?
- The post-processing generated after scanning is converted into energy spectrum image data (SBI)
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2021to 21 Jun 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 1.Since March 2024, I have been visiting our hospital for various reasons and have undergone CT scans involving the pancreas (using energy spectrum CT)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Yu Shi, docter, +8618940259980, 18940259980@163.com
About this study
Official title: Assessment of Pancreatic Physiological and Pathological Characteristics Based on Spectral CT Feature Parameters: A Related Study
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.
Read the detailed description
Dual-Energy CT (DECT) is a widely recognized technology, especially in its applications for the abdominal and pelvic regions. Pancreatology is an ideal application of the many advantages offered by dual-energy post-processing. DECT can characterize specific tissues or materials/elements, generate virtual unenhanced and monochromatic images, and quantify iodine uptake; these unique capabilities make DECT a perfect technology for supporting tumor detection and characterization as well as treatment monitoring, while also reducing radiation and iodine doses and improving metal artifacts. The pancreas' special endocrine function makes pancreatic tissue highly sensitive to individual variations. Researchers have studied the accumulation of pancreatic fat in patients with obesity and metabolic syndrome, suggesting that obesity, increased age, male gender, hypertension, dyslipidemia, alcohol, and hyperferritinemia can cause ectopic fat accumulation in the pancreas, described analogously to "fatty liver" as "fatty pancreas." Age is also an important factor leading to exocrine dysfunction of the pancreas. Studies on the pancreatic features of patients with type II diabetes have indicated that this condition can severely affect pancreatic atrophy/ irregular morphology and fat deposition. Overall, precise characterization of pancreatic tissue is a crucial part of evaluating diagnoses related to pancreatic diseases. Compared to traditional CT, spectral CT provides ample data that can better assist in diagnosing pancreatic diseases.
However, it corresponds that the pancreas itself is very sensitive to certain non-pancreatic primary diseases, even some special abnormal physiological states (such as obesity). When investigators evaluate the special changes of primary pancreatic diseases, it's challenging to exclude the impacts of these factors completely. For some data abnormalities, it's sometimes unclear whether they are caused solely by primary diseases, or not only by primary diseases, nor is it certain whether the effects of primary diseases and these other states on the data are synergistic or antagonistic. Therefore, collecting and researching pancreatic-related spectral data from patients with non-pancreatic primary diseases coming for consultation is a premise for us to use spectral CT feature parameters to assess the relationship between pancreatic physiological and pathological characteristics.
- Conditions
- Diagnose Disease
- Being tested
- The post-processing generated after scanning is converted into energy spectrum image data (SBI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The post-processing generated after scanning is converted into energy spectrum image data (SBI)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| test group | Post processing patient data using energy spectrum CT Receives: 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 Receives: Other: The post-processing generated after scanning is converted into energy spectrum image data (SBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
spectral imaging data(SBI)
Using Philips Intellispace Portal software to reconstruct spectral imaging data images
Measured: 21/3/2025
ROI area（mm2）
Using Philips Intellispace Portal software to delineate the Region of Interest (ROI)
Measured: 21/3/2025
Secondary outcomes (1)
single-energy CT value
Measure the single-energy CT value(Hu)
Measured: 21/3/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start21 Jan 2021
- Primary completion21 Jun 2027 (estimated)
- Study completion21 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnose DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Yu Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Shi, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510036
- Sponsor's protocol ID
- ShengjingH-shen
- Status last verified
- Dec 2024
- First submitted
- 12 Jun 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pancreatic Physiological and Pathological Characteristics Based on Spectral CT Feature Parameters: A Related Study
- ClinicalTrials.gov ID
- NCT06510036
- Acronym / sponsor ID
- ShengjingH-shen
- Conditions
- Diagnose Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Yu ShiUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 21 Jun 2027 (estimated)
- Study completion
- 21 Jun 2028 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dual-Energy CT (DECT) is a widely recognized technology, especially in its applications for the abdominal and pelvic regions. Pancreatology is an ideal application of the many advantages offered by dual-energy post-processing. DECT can characterize specific tissues or materials/elements, generate virtual unenhanced and monochromatic images, and quantify iodine uptake; these unique capabilities make DECT a perfect technology for supporting tumor detection and characterization as well as treatment monitoring, while also reducing radiation and iodine doses and improving metal artifacts. The pancreas' special endocrine function makes pancreatic tissue highly sensitive to individual variations. Researchers have studied the accumulation of pancreatic fat in patients with obesity and metabolic syndrome, suggesting that obesity, increased age, male gender, hypertension, dyslipidemia, alcohol, and hyperferritinemia can cause ectopic fat accumulation in the pancreas, described analogously to "fatty liver" as "fatty pancreas." Age is also an important factor leading to exocrine dysfunction of the pancreas. Studies on the pancreatic features of patients with type II diabetes have indicated that this condition can severely affect pancreatic atrophy/ irregular morphology and fat deposition. Overall, precise characterization of pancreatic tissue is a crucial part of evaluating diagnoses related to pancreatic diseases. Compared to traditional CT, spectral CT provides ample data that can better assist in diagnosing pancreatic diseases.
However, it corresponds that the pancreas itself is very sensitive to certain non-pancreatic primary diseases, even some special abnormal physiological states (such as obesity). When investigators evaluate the special changes of primary pancreatic diseases, it's challenging to exclude the impacts of these factors completely. For some data abnormalities, it's sometimes unclear whether they are caused solely by primary diseases, or not only by primary diseases, nor is it certain whether the effects of primary diseases and these other states on the data are synergistic or antagonistic. Therefore, collecting and researching pancreatic-related spectral data from patients with non-pancreatic primary diseases coming for consultation is a premise for us to use spectral CT feature parameters to assess the relationship between pancreatic physiological and pathological characteristics.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | – | Other: The post-processing generated after scanning is converted into energy spectrum image data (SBI)Post processing patient data using energy spectrum CT |
| control group | – | Other: The post-processing generated after scanning is converted into energy spectrum image data (SBI)Collect traditional CT data that can correspond to spectral CT since the establishment of PACS database to form a comparison |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1.Since March 2024, I have been visiting our hospital for various reasons and have undergone CT scans involving the pancreas (using energy spectrum CT)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The post-processing generated after scanning is converted into energy spectrum image data (SBI)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. | Other | control group, test group |
Primary outcome
spectral imaging data(SBI)
Time frame: 21/3/2025
Using Philips Intellispace Portal software to reconstruct spectral imaging data images
ROI area（mm2）
Time frame: 21/3/2025
Using Philips Intellispace Portal software to delineate the Region of Interest (ROI)
1 secondary outcome
single-energy CT value
Time frame: 21/3/2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnose Disease, run by Yu Shi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Shi, doctor (18940259980, 18940259980@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spectral imaging data(SBI) (time frame: 21/3/2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.