Evaluating tumor regression in rectal cancer after neoadjuvant therapy using advanced imaging techniques
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.
This study is testing a new imaging method to see how well treatment has worked for people with advanced rectal cancer after they receive therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Chongqing) |
| Trial ID | NCT06318234 on ClinicalTrials.gov |
What this trial studies
This project aims to assess the effectiveness of 18F-FAPI combined with 18F-FDG PET/MRI imaging in evaluating the grading of rectal cancer after neoadjuvant therapy in patients with advanced rectal cancer. The study involves a correlation analysis of tumor regression with the expression levels of FAP and GLUT1 in postoperative specimens. Additionally, a diagnostic model will be constructed to predict the degree of tumor regression based on imaging and histopathological data. The goal is to provide a quantitative assessment that can guide treatment decisions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed advanced rectal adenocarcinoma who have not received prior chemotherapy or immunotherapy.
Not a fit: Patients with severe comorbidities, autoimmune diseases, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of tumor regression evaluations, leading to better treatment planning for rectal cancer patients.
How similar studies have performed: While the use of PET/MRI imaging in cancer evaluation is established, the specific combination of 18F-FAPI and 18F-FDG for rectal cancer regression grading is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed as rectal adenocarcinoma, with baseline clinical staging of T3\~4 and/or N+; * No distant metastasis; * Not receiving chemotherapy or any other anti-tumor treatment before enrollment; * Has not received immunotherapy before enrollment and is able to adhere to the protocol during the study period (neoadjuvant therapy of short-term radiotherapy sequential chemotherapy combined with immunotherapy); * After neoadjuvant therapy, 18F-FAPI and 18F-FDG PET/MRI imaging were performed within 7 days before surgery, and the two scans were collected over two days; * Patient age ≥ 18 years old Exclusion Criteria: * Pregnant or lactating patients; * Patients with severe heart disease in clinical practice; * Organ transplantation requires immunosuppressive therapy and long-term use of hormone therapy; * Patients with autoimmune diseases; * Serious uncontrolled recurrent infections or other serious uncontrolled comorbidities; * The imaging quality is poor and cannot be used for diagnosis and evaluation; * Fasting blood glucose levels are higher than 11.1 mmol/L; * Patients with contraindications for MRI examination.
Where this trial is running
Chongqing
- Department of Nuclear Medicine, Daping Hospital of Army Medical University — Chongqing, China (Recruiting)
Study contacts
- Study coordinator: Xiao Chen, Ph.D
- Email: xiaochen229@foxmail.com
- Phone: +8615922970174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.