NCT06769828|Recruiting
Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA
Ga-68-FAPI-46
Diagnostic Performances of Ga-68-FAPI-46 PET in CRC Patients with Rising Serum CEA During the Post-treatment Surveillance
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Ga-68-FAPI-46
Diagnostic Performances of Ga-68-FAPI-46 PET in CRC Patients with Rising Serum CEA During the Post-treatment Surveillance
Sponsor study identifier
interventional
30
1 country
1
Study Start
February 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 6, 2025
Actual (reported)January 10, 2025
Actual (reported)February 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Sensitivity, Specificity, and Accuracy of Ga-68-FAPI-46 PET for CRC Recurrence Detection
Evaluate the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET in detecting colorectal cancer recurrence. Pathological results will be used as the reference standard where available, or clinical follow-up will be used in cases where tissue sampling is not feasible.
Within 6 months of PET imaging.
Comparison of Ga-68-FAPI-46 PET and FDG PET in CRC Recurrence Detection
Compare the diagnostic performance of Ga-68-FAPI-46 PET and F-18-FDG PET in detecting colorectal cancer recurrence, including sensitivity, specificity, and accuracy.
Within 6 months of PET imaging.
Clinical Impact of Ga-68-FAPI-46 PET on Management Decisions
Immediately after completion of PET imaging and report review.
Participants in this arm will undergo a Ga-68-FAPI-46 PET scan within 2-14 days after their F-18-FDG PET scan. Ga-68-FAPI-46 will be administered via intravenous injection at a dose of 1.8-2.2 MBq per kilogram of body weight, with a maximum dose of 200 MBq. The scan will be performed 30-90 minutes after injection. This study aims to evaluate the diagnostic performance of Ga-68-FAPI-46 PET in detecting colorectal cancer recurrence in patients with elevated serum carcinoembryonic antigen (CEA), compared to F-18-FDG PET.
Ga-68-FAPI-46 PET scan in colorectal cancer
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Beitou, 1125019, Taiwan
First Submitted
January 6, 2025
First Posted
January 10, 2025
Study Start
February 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 14, 2026
Estimated (date passed)Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 22, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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