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

Launched by KOO FOUNDATION SUN YAT-SEN CANCER CENTER · Jan 6, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new type of PET scan called Ga-68-FAPI-46 to see how well it can detect if colorectal cancer (CRC) has come back in patients who have previously had surgery. The focus is on patients who have high levels of a substance in their blood called CEA, which can indicate cancer recurrence. Researchers want to compare this new scan's effectiveness with a standard scan (F-18-FDG PET) to improve how we monitor patients after treatment. The study will involve 30 participants who will undergo imaging studies and follow-up care to track their health.

To be eligible for the trial, participants need to be at least 20 years old and should have undergone surgery for colorectal cancer that was meant to remove the disease completely. They must also have had a rise in their CEA levels that suggests the cancer may have returned. Participants should be able to lie flat for about 30 minutes during the scan and must be willing to sign consent to join the study. Importantly, individuals who are pregnant, have severe kidney issues, or other serious medical conditions may not qualify. Through this trial, participants can help researchers learn more about the best ways to detect cancer recurrence, which could benefit future patients.

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Eligibility criteria

• 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)