TheranosticTrials.org

Clinical Trial · NCT06769828

Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA

Overview

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.

Sponsor

Unknown Organization

Phase

N/A

Contacts

Cheng Ling Yang, B.Rad. (CONTACT)

androgyny@kfsyscc.org

+886 28970011

Yu Yi Huang, MD (CONTACT)

yuyi@kfsyscc.org

+886 28970011

ClinicalTrials.gov

NCT06769828

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

FAPI-46

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Already performed or scheduled for FDG PET scanning examination. (5) Able to lie flat for at least 30 minutes.
  • 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.
  • ECOG grade 0-2.
  • The timing of F-18-FDG usage in this trial follows the " 2023 - Colorectal Cancer Treatment Principles" of our institution.
  • 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.

Exclusion

  • Inability to undergo the necessary PET scan procedure