NCT06318234

PET/MR Evaluation of Regression Grading After Neoadjuvant Therapy for Rectal Cancer

Research Focused on Developing and Assessing a Non-intrusive Diagnostic Approach for Grading Tumor Regression Post-neoadjuvant Treatment in Rectal Cancer, Utilizing 18F-FAPI in Conjunction With FDG PET/MR Imaging.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 32 (estimated)
• Sponsor: Xiao Chen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This project aims to evaluate the role of 18F-FAPI combined with 18F-FDG PET/MRI imaging in quantitatively and accurately evaluating the grading of rectal cancer after SCRT neoadjuvant therapy in patients with advanced rectal cancer as the research object, with postoperative histopathological analysis as the reference index, and to assess the ability of patients to achieve pCR. A diagnostic model and evaluation system will also be constructed.

Detailed description

1. Correlation analysis between the expression levels of FAP and GLUT1 and the degree of tumor regression in rectal cancer The study focuses on patients with advanced rectal cancer treated with SCRT neoadjuvant therapy, and conducts immunohistochemical staining of FAP and GLUT1 (glucose transporter 1) on postoperative specimens to evaluate histopathological changes related to the degree of rectal cancer tumor regression. The expression levels of FAP and GLUT1 and the grading of tumor regression are quantitatively analyzed, and their correlation is analyzed to explore the correlation between the expression levels of FAP and GLUT1 in the lesions of neoadjuvant therapy patients and the degree of tumor regression. 2. Construction and validation of a diagnostic model for the degree of tumor regression in rectal cancer after neoadjuvant therapy using 18F-FAPI combined with 18F-FDG PET/MRI imaging The patient underwent preoperative 18F-FAPI and 18F-FDG PET/MRI imaging, followed by immunohistochemical staining of FAP and GLUT1 on postoperative specimens and evaluation of histopathological changes related to the degree of rectal cancer tumor regression. The patient's uptake of 18F-FAPI and 18F-FDG (SUVmax, SUVmean, SUVpeak, FAPI metabolic volume, MTV, TBR, TLG), expression levels of FAP and GLUT1, and degree of tumor regression were quantitatively analyzed, and the correlation between the patient's uptake of 18F-FAPI and 18F-FDG and the degree of tumor regression was explored. A graded diagnostic model and evaluation system were constructed to verify their effectiveness. 3. Comparison of the efficacy of PET/MR-TRG and MR-TRG in assessing pTRG after neoadjuvant therapy for rectal cancer Compare the constructed PET/MR tumor regression grading diagnostic model with the commonly used clinical imaging diagnostic method MRI in evaluating the efficacy, pTRG, and pCR of neoadjuvant therapy for rectal cancer.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	18F-FAPI，18F-FDG	FAPI and FDG combined with PET/MR imaging in patients with rectal cancer after neoadjuvant therapy

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-03-19
• Last updated: 2024-03-19

Locations

1 site across 1 country: China