Using Ga-68-FAPI-46 PET scans to detect colorectal cancer recurrence
Diagnostic Performances of Ga-68-FAPI-46 PET in CRC Patients with Rising Serum CEA During the Post-treatment Surveillance
This study is testing if a new type of PET scan can better detect colorectal cancer recurrence in patients with high CEA levels after surgery compared to the standard scan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 20 Years to 100 Years |
| Sex | All |
| Sponsor | Koo Foundation Sun Yat-Sen Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taipei, Beitou) |
| Trial ID | NCT06769828 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older who have undergone curative surgery for colorectal cancer and have elevated serum CEA levels indicating potential recurrence.
Not a fit: Patients who are pregnant, breastfeeding, or have severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and earlier detection of colorectal cancer recurrence, improving patient outcomes.
How similar studies have performed: While the use of Ga-68-FAPI-46 PET is a novel approach, similar imaging techniques have shown promise in other studies for detecting cancer recurrence.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Taipei, Beitou
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.