Clinical trial · Interventional
Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA
Diagnostic Performances of Ga-68-FAPI-46 PET in CRC Patients with Rising Serum CEA During the Post-treatment Surveillance
- 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 single-center, phase II clinical trial investigates the diagnostic efficacy of Ga-68-FAPI-46 PET scans in detecting colorectal cancer (CRC) recurrence during post-treatment surveillance, particularly in patients with elevated serum carcinoembryonic antigen (CEA). The study compares the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET with the conventional F-18-FDG PET scans, aiming to enhance recurrence detection in CRC patients who underwent curative surgery. Thirty participants will be enrolled and monitored through imaging studies and clinical follow-up.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Recurrent | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ga-68-FAPI-46 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ga-68-FAPI-46 PET scan in colorectal cancer
- description
- Participants in this arm will undergo a Ga-68-FAPI-46 PET scan within 2-14 days after their F-18-FDG PET scan. Ga-68-FAPI-46 will be administered via intravenous injection at a dose of 1.8-2.2 MBq per kilogram of body weight, with a maximum dose of 200 MBq. The scan will be performed 30-90 minutes after injection. This study aims to evaluate the diagnostic performance of Ga-68-FAPI-46 PET in detecting colorectal cancer recurrence in patients with elevated serum carcinoembryonic antigen (CEA), compared to F-18-FDG PET.
- interventionNames
- Drug: Ga-68-FAPI-46
Primary outcomes (2)
- measure
- Sensitivity, Specificity, and Accuracy of Ga-68-FAPI-46 PET for CRC Recurrence Detection
- timeFrame
- Within 6 months of PET imaging.
- description
- Evaluate the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET in detecting colorectal cancer recurrence. Pathological results will be used as the reference standard where available, or clinical follow-up will be used in cases where tissue sampling is not feasible.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 20 years old * The surgical intervention for colorectal cancer aims for curative resection, with the goal of achieving a disease-free status that persists for six months or more, as assessed clinically and through imaging studies. * Elevated serum CEA levels: Exceeding the laboratory's normal range (5 ng/ml) or, but not surpassing 13 ng/ml; using the individual's post-surgery +/- adjuvant chemotherapy or targeted therapy minimum value as a baseline, a consecutive increase of more than 10% for two times or as determined by the attending physician suggests suspicion of recurrence. * Already performed or scheduled for FDG PET scanning examination. (5) Able to lie flat for at least 30 minutes. * Signing the subject consent form. * ECOG grade 0-2. * The timing of F-18-FDG usage in this trial follows the " 2023 - Colorectal Cancer Treatment Principles" of our institution. Exclusion Criteria: * pregnant woman and breastfeeding women * severe renal impairment (eGRF\< 30ml/min) * Known or suspected allergy to radiopharmaceuticals * Simultaneously or previously diagnosed with malignant tumors other than colorectal cancer. * Inability to undergo the necessary PET scan procedure * Refusal or unwillingness to sign the informed consent form * Severe medical conditions (severe disabilities, mental disorders)
References
Publications (0)
Data not yet available