Actively Recruiting
Diagnostic Performance of Ga-68-FAPI-46 PET Scans for Detecting Colorectal Cancer Recurrence in Patients with Elevated Serum CEA During Post-Treatment Follow-Up
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
Researchers are assessing the effectiveness of Ga-68-FAPI-46 PET scans in detecting the return of colorectal cancer (CRC) in patients who have had surgery and show rising levels of a blood marker called carcinoembryonic antigen (CEA). The trial focuses on improving the detection of cancer recurrence during post-treatment follow-up, especially in patients with stages II and III CRC. This is a phase II, single-center study comparing this new imaging method to the standard F-18-FDG PET scans. Participants will receive both Ga-68-FAPI-46 PET and F-18-FDG PET scans to locate possible recurrent tumors. The Ga-68-FAPI-46 agent targets a protein found in the tumor environment and may provide clearer images due to better tumor uptake and quicker clearance from normal tissues. The study involves 30 participants who have already had or are scheduled for FDG PET scans and will undergo these imaging assessments during the surveillance period after surgery. Throughout the study, participants will be monitored through imaging and clinical follow-ups to confirm the presence or absence of recurrence. Researchers will compare the sensitivity, specificity, and accuracy of both PET scan types within six months of imaging. Safety and data privacy are ensured following Good Clinical Practice guidelines, and participant involvement includes consenting and being able to lie still during the scans.
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
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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
C
Cheng Ling Yang, B.Rad.
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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