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

NCT06318234 | Recruiting

• 1 other identifier: 202435
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Immunotherapy; New assistance; Efficacy evaluation; 18F-FAPI; 18F-FDG; PET/MRI

Outcome Measures

Primary Outcomes (1)

• Evaluation efficacy of tumor regression level

  The sensitivity, specificity, positive predictive value (PPV), negative predictive value

  Completed within half year after end of the study

Secondary Outcomes (3)

• expression of FAP

  completed within one week after surgery

• expression of GLUT1

  completed within one week after surgery

• SUV

  Completed within one week after PET examination

Study Arms (1)

After neoadjuvant therapy for rectal cancer

(1) Pathologically confirmed as rectal adenocarcinoma, with baseline clinical staging of T3\~4 and/or N+; (2) No distant metastasis; (3) Not receiving chemotherapy or any other anti-tumor treatment before enrollment; (4) 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); (5) 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; (6) Patient age ≥ 18 years old; (7) The patient voluntarily participates and signs an informed consent form.

Diagnostic Test: 18F-FAPI，18F-FDG

Interventions

18F-FAPI，18F-FDG DIAGNOSTIC_TEST

FAPI and FDG combined with PET/MR imaging in patients with rectal cancer after neoadjuvant therapy

After neoadjuvant therapy for rectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects the investigators selected are adults who are not restricted by gender.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiao Chen: lead

Study Sites (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University

Chongqing, China

RECRUITING

Related Publications (1)

• Wang Y, Shen L, Wan J, Zhang H, Wu R, Wang J, Wang Y, Xu Y, Cai S, Zhang Z, Xia F. Neoadjuvant chemoradiotherapy combined with immunotherapy for locally advanced rectal cancer: A new era for anal preservation. Front Immunol. 2022 Dec 8;13:1067036. doi: 10.3389/fimmu.2022.1067036. eCollection 2022.

  PMID: 36569918 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

histopathological findings obtained from biopsy or resected surgical specimens

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Xiao Chen, Ph.D

CONTACT

+8615922970174; xiaochen229@foxmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 19, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)