Clinical trial NCT06510036: Assessment of Pancreatic Physiological and Pathological Characteristics Based on Spectral CT
Official title: Assessment of Pancreatic Physiological and Pathological Characteristics Based on Spectral CT Feature Parameters: A Related Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diagnose Disease
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

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

Primary outcomes:
measure: spectral imaging data(SBI)
timeFrame: 21/3/2025
measure: ROI area（mm2）
timeFrame: 21/3/2025
Secondary outcomes:
measure: single-energy CT value
timeFrame: 21/3/2025
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
References: