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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer Recurrent
• Interventions: Drug: Ga-68-FAPI-46

• Registration Number: NCT06769828
• Lead Sponsor: Koo Foundation Sun Yat-Sen Cancer Center

Brief Summary

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.

Detailed Description

Colorectal cancer (CRC) is one of the leading causes of cancer-related mortality, with a significant recurrence rate following curative surgery, particularly in stages II and III. Early detection of asymptomatic recurrence is critical for initiating salvage treatment. Serum CEA elevation is a marker for recurrence, necessitating advanced imaging tools for precise localization.

This study evaluates the use of Ga-68-FAPI-46, a novel imaging agent targeting fibroblast activation protein (FAP), which is overexpressed in the tumor stroma. Ga-68-FAPI-46 demonstrates higher tumor uptake and faster clearance from normal tissues compared to F-18-FDG, offering a potential diagnostic advantage. Participants will undergo both F-18-FDG PET and Ga-68-FAPI-46 PET scans, with lesion detection validated through pathology or clinical follow-up.

The trial aims to determine the diagnostic performance of Ga-68-FAPI-46 PET in terms of sensitivity, specificity, positive predictive value, and negative predictive value, using the McNemar test for statistical comparison. The study also emphasizes participant safety and data protection, adhering to Good Clinical Practice (GCP) guidelines.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22
• Study Start: 2025-02-01
• Primary Completion: 2026-04-14
• Study Completion: 2026-04-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age ≥ 20 years old
• 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.
• 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.

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

Exclusion Criteria

• pregnant woman and breastfeeding women
• severe renal impairment (eGRF< 30ml/min)
• Known or suspected allergy to radiopharmaceuticals
• Simultaneously or previously diagnosed with malignant tumors other than colorectal cancer.
• Inability to undergo the necessary PET scan procedure
• Refusal or unwillingness to sign the informed consent form
• Severe medical conditions (severe disabilities, mental disorders)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ga-68-FAPI-46 PET scan in colorectal cancer	Ga-68-FAPI-46	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity, Specificity, and Accuracy of Ga-68-FAPI-46 PET for CRC Recurrence Detection	Within 6 months of PET imaging.	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.
Comparison of Ga-68-FAPI-46 PET and FDG PET in CRC Recurrence Detection	Within 6 months of PET imaging.	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Impact of Ga-68-FAPI-46 PET on Management Decisions	Immediately after completion of PET imaging and report review.	Evaluate the impact of Ga-68-FAPI-46 PET imaging on clinical decision-making through a questionnaire completed by the principal investigator before and after receiving the PET results. The questionnaire assesses changes in diagnosis, treatment planning, and patient management.

Trial Locations

Locations (1)

Koo Foundation Sun Yat-Sen Cancer Center; 🇨🇳 Taipei, Beitou, Taiwan