Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA

Summary

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.

Eligibility

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)

Conditions2

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