- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06158776
Predicting Rectal Adenoma With Canceration and Investigating Mechanism Based on Multimodal MRI and Biochemical Model
November 28, 2023 updated by: Aiyin Li
Research on the Prediction and Mechanism of Rectal Adenoma Canceration Based on Radiomics of Multimodal MRI Combined With Clinical Indicators
In this retrospective study is to establish a diagnostic model for rectal adenoma canceration.
The model will include multimodal comprehensive HR-T2WI morphological score, IVIM functional imaging and radiomics features, and clinical indicators such as tumor markers, serum Gelsolin protein and peripheral blood inflammatory cell ratio.
It can be to provide accurate diagnostic information for patients before surgery, which is of great value for formulating personalized treatment plans and improving the prognosis of patients.
Study Overview
Status
Completed
Conditions
Detailed Description
Imaging tests is the main method for evaluating rectal mass, especially MRI, which has been widely used in the preoperative diagnosis of rectal mass disease due to its very good soft tissue resolution.
Previous studies in our group found that HR-T2WI-based radiomics, HR-T2WI-based morphology, and IVIM-based functional imaging can be used for the diagnosis of adenoma canceration.
In addition to imaging, other tests, such as peripheral blood tests, can also reflect the development and progression of adenocarcinoma by counting tumor markers (colorectal tumor markers mainly CEA, AFP, CA199, CA724, CA50, CA242), inflammatory cell ratio (lymphocyte/C-reactive protein ratio, neutrophil/lymphocyte ratio, lymphocyte/monocytes ratio), and special types of proteins (such as coagulant protein).This study identifies the progression of adenoma to carcinoma by analyzing the combined cellular, morphological, and functional changes in adenoma carcinomas, with the expectation that multimodal co-diagnosis will improve the accuracy of clinical diagnosis.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shandong
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Jinan, Shandong, China, 250014
- Qianfoshan Hosptial
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Collect patients who come to our hospital for surgery due to rectal mass, and preoperative colonoscopy is diagnosed as adenoma or suspected adenoma cancerous, and did not receive any treatment before surgery.
Exclusion criteria: patients with malignant tumors of other organs, patients who have received neoadjuvant chemoradiotherapy before surgery, patients with other acute and chronic inflammation, and claustrophobia.
Description
Inclusion Criteria:
- surgical resection
- pathologically confirmed rectal adenoma or rectal adenoma with canceration
- rectal MRI examination including IVIM-DWI, within two weeks before surgery
Exclusion Criteria:
- preoperative treatment
- poor image quality, including intestinal gas or fecal artifact and IVIM image fitting error
- no surgical resection but colonoscopy
- pathologically confirmed rectal cancer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
morphological scoring based on HR-T2WI
Time Frame: 5-10 minutes
|
Radiologists interpret the lesion according to the performance of HR-T2WI, and the interpretation criteria are whether the mucosal layer signal is continuous, whether the intestinal wall is wrinkled, and whether the tumor has external convexity.
|
5-10 minutes
|
IVIM parameter
Time Frame: 10-15 minutes
|
IVIM sequence images were analyzed using Functool MADC software, and the region of interest (ROI) was placed in the solid region of the tumor, continuously outlining the edges of the hypertensive lesions.
The D, D, and F values of the lesion are then measured and recorded.
|
10-15 minutes
|
Radiomics score
Time Frame: 10-15 minutes
|
Tumor volume is manually sketched as ROI by RadCloudv2.2 platform on HR-T2WI images.
Three sets of features were extracted based on VOI, and then the screened feature values were scored using software R.
|
10-15 minutes
|
Clinical indicators
Time Frame: 3-7 minutes
|
The levels of tumor markers and inflammatory cell indexes of all patients in this study were collected, and meaningful indicators were statistically analyzed as one of the identification items.
Tumor markers mainly include CEA, AFP, CA199, CA724, CA50 and CA242,inflammatory cell ratios include lymphocyte/C-reactive protein ratio, neutrophil/lymphocyte ratio and lymphocyte/monocytes ratio, in addition to special types of proteins (such as coagulant protein).
|
3-7 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nomogram
Time Frame: 10-20 minutes
|
Radiomics features were extracted based on tumor volume and screened to obtain meaningful features.
Finally, the radiomics feature scores were obtained by weighted calculation as omics parameters.The T2 morphological score, IVIM parameters, meaningful clinical indicators and weighted omics scores were used as relevant factors to construct a concise nomogram for predicting the canceration of rectal adenoma.
|
10-20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Aiyin Li, Ph.D., Qianfoshan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
June 15, 2022
Study Registration Dates
First Submitted
December 23, 2022
First Submitted That Met QC Criteria
November 28, 2023
First Posted (Actual)
December 6, 2023
Study Record Updates
Last Update Posted (Actual)
December 6, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S1119
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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