Actively Recruiting
Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA
Led by Koo Foundation Sun Yat-Sen Cancer Center · Updated on 2025-01-22
30
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Underwent surgery for colorectal cancer aimed at complete removal with disease-free status for 6 months or more confirmed by clinical and imaging assessments
- Elevated serum CEA levels exceeding normal range (5 ng/ml) but not exceeding 13 ng/ml, or a consecutive increase of more than 10% twice or as determined by the physician
- Already had or scheduled for FDG PET scan
- Able to lie flat for at least 30 minutes
- Signed informed consent form
- ECOG performance status grade 0 to 2
- F-18-FDG usage follows institutional colorectal cancer treatment guidelines
You will not qualify if you...
- Pregnant or breastfeeding women
- Severe kidney impairment with estimated glomerular filtration rate (eGFR) less than 30 ml/min
- Known or suspected allergy to radiopharmaceuticals
- Having or suspected to have cancers other than colorectal cancer
- Unable to undergo PET scan procedure
- Refusal or unwillingness to sign informed consent
- Severe medical conditions such as severe disabilities or mental disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Beitou, Taiwan, 1125019
Actively Recruiting
Research Team
Y
Yu Yi Huang, MD
CONTACT
C
Cheng Ling Yang, B.Rad.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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