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

NCT06769828 | Recruiting

• 1 other identifier: KF-FAPI46-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Recurrent

Keywords

Ga-68-FAPI-46 PET/CT; Colorectal cancer (CRC)

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (1)

• Clinical Impact of Ga-68-FAPI-46 PET on Management Decisions

  Immediately after completion of PET imaging and report review.

Study Arms (1)

Ga-68-FAPI-46 PET scan in colorectal cancer

EXPERIMENTAL

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.

Drug: Ga-68-FAPI-46

Interventions

Ga-68-FAPI-46 DRUG

Ga-68-FAPI-46 PET scan in colorectal cancer

Also known as: PET/CT

Ga-68-FAPI-46 PET scan in colorectal cancer

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Koo Foundation Sun Yat-Sen Cancer Center: lead

Study Sites (1)

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Beitou, 1125019, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Yu Yi Huang, MD

CONTACT

+886 28970011; yuyi@kfsyscc.org

Cheng Ling Yang, B.Rad.

CONTACT

+886 28970011; androgyny@kfsyscc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: February 1, 2025
• Primary Completion: April 14, 2026
• Study Completion: April 14, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

TW (1)