Comparison of [68Ga]Ga-CTR-FAPI and 18F-FDG PET/MRI for Lymph Node Staging in Rectal Cancer

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07552207
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PET/MRI with 18F-FDG and [68Ga]Ga-CTR-FAPI — DIAGNOSTIC_TEST
    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).

Study Details

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.

Key Dates

First listed
Apr 27, 2026
Start date
Apr 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Rectal Cancer Patients
    Patients with confirmed middle to high rectal adenocarcinoma who are scheduled for radical surgery.

Primary Outcome Measure

Sensitivity and Specificity of Lymph Node Metastasis Detection [ Time Frame: Up to 30 days post-surgery ]

Central Contacts

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