Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastases | — | UNRESOLVED | — |
| PET / MR | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/MRI with 18F-FDG and [68Ga]Ga-CTR-FAPI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rectal Cancer Patients
- description
- Patients with confirmed middle to high rectal adenocarcinoma who are scheduled for radical surgery.
- interventionNames
- Diagnostic Test: PET/MRI with 18F-FDG and [68Ga]Ga-CTR-FAPI
Primary outcomes (1)
- measure
- Sensitivity and Specificity of Lymph Node Metastasis Detection
- timeFrame
- Up to 30 days post-surgery
- description
- Comparison of the sensitivity and specificity of \[68Ga\]Ga-CTR-FAPI and 18F-FDG PET/MRI in determining lymph node metastasis at both the individual lymph node level and the patient level. Sensitivity is defined as the proportion of imaging-positive and pathology-positive nodes out of all pathology-positive nodes. Specificity is defined as the proportion of imaging-negative and pathology-negative nodes out of all pathology-negative nodes.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available