Using Ga-68-FAPI-46 PET scans to detect colorectal cancer recurrence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of Ga-68-FAPI-46 PET scans in identifying recurrence of colorectal cancer (CRC) in patients with elevated serum carcinoembryonic antigen (CEA) levels after curative surgery. The study compares the diagnostic performance of Ga-68-FAPI-46 PET with traditional F-18-FDG PET scans, focusing on sensitivity, specificity, and accuracy. Thirty participants will undergo both imaging modalities, with results validated through pathology or clinical follow-up. The goal is to improve early detection of asymptomatic CRC recurrence, which is crucial for timely treatment.

Why it matters

Who can join: the full rules

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)

Where it's running

• Koo Foundation Sun Yat-Sen Cancer Center
  Taipei, Beitou, Taiwan Recruiting

Study contacts

• Study coordinator: Yu Yi Huang, MD
• Email: yuyi@kfsyscc.org
• Phone: +886 28970011

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.