Actively Recruiting

Phase Not Applicable
Age: 20Years - 100Years
All Genders
ID06769828

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

Age: 20Years - 100Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Beitou, Taiwan, 1125019

Actively Recruiting

Loading map...

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

Similar Trials

A Dose-Expansion Trial Studying Intravenous HNF4α srRNA (CD-...

Colorectal Cancer Metastatic

Actively Recruiting

1 location

Development and Validation of Microbiota and Metabolite-base...

Colorectal Polyp

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here