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

NCT06158776 | Completed

• 1 other identifier: S1119
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Adenoma

Keywords

Rectal Adenoma;Canceration;Magnetic resonance imaging; Radiomics

Outcome Measures

Primary Outcomes (4)

• morphological scoring based on HR-T2WI

  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

  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

  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

  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 Outcomes (1)

• Nomogram

  10-20 minutes

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aiyin Li: lead

Study Sites (1)

Qianfoshan Hosptial

Jinan, Shandong, 250014, China

Location

Study Officials

• Aiyin Li, Ph.D.

  Qianfoshan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: December 6, 2023
• Study Start: January 1, 2022
• Primary Completion: May 31, 2022
• Study Completion: June 15, 2022
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)