Actively Recruiting

Phase Not Applicable
Age: 20Years - 100Years
All Genders
NCT06769828

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

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

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Trial Site Locations

Total: 1 location

1

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Beitou, Taiwan, 1125019

Actively Recruiting

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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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