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

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Conditions studied: Rectal Cancer, Lymph Node Metastases, PET / MR

In brief

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 facts

Study ID

NCT07552207

Run by

Peking University Cancer Hospital & Institute

People needed

30

Starts

2026-04-01

Expected to finish

2028-12-31

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed rectal adenocarcinoma by pathological biopsy.
• Lower margin of the tumor is ≥ 5 cm and ≤15 cm from the anal verge.
• Planned to undergo radical surgery.
• ECOG performance status score ≤ 2.
• Patient is willing to undergo PET/MRI examination.

You may not qualify if…

• History of pelvic radiotherapy or chemotherapy.
• Concurrent with other malignant tumors or active infections.
• Pregnant or unable to sign the informed consent form.
• Claustrophobia or inability to tolerate MRI examinations due to other reasons.

Full record on ClinicalTrials.gov

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