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

Recruiting now · Not applicable

Conditions studied: Colorectal Cancer Recurrent

In brief

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.

Key facts

Study ID

NCT06769828

Run by

Koo Foundation Sun Yat-Sen Cancer Center

People needed

30

Starts

2025-02-01

Expected to finish

2026-04-14

Last updated by the study team

2025-01-22

Who can join

Age: 20 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Koo Foundation Sun Yat-Sen Cancer Center — Taipei, Beitou, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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