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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • China
    • Shandong
      • Jinan, Shandong, China, 250014
        • Qianfoshan Hosptial

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. surgical resection
  2. pathologically confirmed rectal adenoma or rectal adenoma with canceration
  3. rectal MRI examination including IVIM-DWI, within two weeks before surgery

Exclusion Criteria:

  1. preoperative treatment
  2. poor image quality, including intestinal gas or fecal artifact and IVIM image fitting error
  3. no surgical resection but colonoscopy
  4. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aiyin Li

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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