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NCT Number: NCT06158776

Predicting Rectal Adenoma With Canceration and Investigating Mechanism Based on Multimodal MRI and Biochemical Model

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.

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Key information

Conditions

Rectal Adenoma

Sex eligibility

All sexes

Study type

Observational

Primary location

Qianfoshan Hosptial

Jinan, Shandong, 250014, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Aiyin Li

Other

Registry information

Official study title

Research on the Prediction and Mechanism of Rectal Adenoma Canceration Based on Radiomics of Multimodal MRI Combined With Clinical Indicators

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 6, 2023
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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