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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07552207 on ClinicalTrials.gov