Comparison of [68Ga]Ga-CTR-FAPI and 18F-FDG PET/MRI for Lymph Node Staging in Rectal Cancer
NCT07552207 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-04
Summary
This is a prospective, single-center, diagnostic study designed to compare the accuracy of \[68Ga\]Ga-CTR-FAPI PET/MRI and \[18\]F-FDG PET/MRI for the detection of lymph node metastasis in patients with initially untreated, resectable middle to high rectal cancer. The study aims to evaluate whether \[68Ga\]Ga-CTR-FAPI PET/MRI provides higher sensitivity and specificity than traditional 18F-FDG PET/MRI at both the patient level and the lymph node level.
Conditions
- Rectal Cancer
- Lymph Node Metastases
- PET / MR
Interventions
- DIAGNOSTIC_TEST
-
PET/MRI with 18F-FDG and [68Ga]Ga-CTR-FAPI
Diagnostic Test: 18F-FDG PET/MRI Description: Patients receive an intravenous injection of 18F-FDG (3.7-5.5 MBq/kg). Diagnostic Test: \[68Ga\]Ga-CTR-FAPI PET/MRI Description: Patients receive an intravenous injection of \[68Ga\]Ga-CTR-FAPI (1.8-3.7 MBq/kg).
Sponsors & Collaborators
-
Peking University Cancer Hospital & Institute
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
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