Application of PET/MRI in the Evaluation of the Efficacy of Neoadjuvant Therapy for Locally Advanced Rectal Cancer

NCT06653452 | Recruiting

• 1 other identifier: PUMCH-NM-LARC-FAPI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to include LARC patients receiving neoadjuvant therapy at this center, conducting PET/CT and PET/MR examinations before treatment, and PET/MR examinations before surgery after neoadjuvant therapy. The changes in the lesion before and after treatment will be compared to evaluate the efficacy of neoadjuvant therapy, including: the relief situation of the rectal primary lesion ; lymph node metastasis; local infiltration around the tumor; peritoneal and other distant metastases , etc. The pathological relief diagnosed by surgical pathology is the gold standard, and the predictive efficacy of PET/MR will be evaluated, comparing the advantages and disadvantages of 18F-FDG and 68Ga-FAPI PET/MR, and comparing with traditional PET/CT and rectal MRI to explore the value of PET/MRI in predicting the efficacy of neoadjuvant therapy in LARC patients.

Conditions

Locally Advanced Rectal Cancer (LARC)

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance including sensitivity, specificity, accuracy

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• TNM stage changed by 68Ga-FAPI-04 PET/CT and PET/MR compared to 18F-FDG PET/CT and PET/MR.

  Through study completion, an average of 1 year

Study Arms (1)

18F-FDG PET/CT and PET/MR, 68Ga-FAPI-04 PET/CT and PET/MR

EXPERIMENTAL

After patient enrollment, 68Ga-FAPI-04 PET/CT and PET/MR examinations are performed. Within 1 week before and after the examination, PET/CT and PET/MR is also performed in patients.

Diagnostic Test: 18F-FDG PET/CT and PET/MR scan, 68Ga-FAPI-04 PET/CT and PET/MR scan

Interventions

18F-FDG PET/CT and PET/MR scan, 68Ga-FAPI-04 PET/CT and PET/MR scan DIAGNOSTIC_TEST

Patients with Locally Advanced Rectal Cancer underwent 68Ga-FAPI-04 PET/CT and PET/MR scan after injection of 0.02 to 0.04 mCi/Kg×patient weight (Kg). Within 1 week before and after the examination, 18F-FDG PET/CT and PET/MR is completed.

18F-FDG PET/CT and PET/MR, 68Ga-FAPI-04 PET/CT and PET/MR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Age 18-75 years old; (2) ECOG score 0-2; (3) Pathologically confirmed as rectal adenocarcinoma; (4) The lower edge of the tumor is within 12cm from the anal edge; (5) Clinically staged as cT3-4N0M0 or cTanyN+M0; (6) Untreated patients who have not received radiotherapy, chemotherapy, and surgery, etc.; (7) Good liver and kidney function, can tolerate radiotherapy and surgery; (8) Patients and their families can understand the research plan, voluntarily participate in this research and sign the informed consent form.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Central Study Contacts

Zhaoxia huang, B.S.

CONTACT

86+18929673449; 1261152761@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 22, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

CN (1)