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NCT07552207Not yet recruiting

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

Comparison of the Diagnostic Efficacy of [68Ga]Ga-CTR-FAPI PET/MRI and 18F-FDG PET/MRI for Lymph Node Metastasis in Middle to High Rectal Cancer

Source: ClinicalTrials.gov · Last updated 4 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
20 Apr 2026
Start date
1 Apr 2026
Primary completion date
31 Dec 2027
Lead sponsor
Peking University Cancer Hospital & Institute
NCT number
NCT07552207

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 1 Apr 2026 to the primary completion date, 31 Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent with other malignant tumors or active infections.

Other illness

  • History of pelvic radiotherapy or chemotherapy.

Other

  • Pregnant or unable to sign the informed consent form.
  • Claustrophobia or inability to tolerate MRI examinations due to other reasons.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.