Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ga-68-FAPI-46.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer Recurrent. Basic parameters: 20 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnostic Performances of Ga-68-FAPI-46 PET in CRC Patients with Rising Serum CEA During the Post-treatment Surveillance
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.
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.
Interventions
- Drug Ga-68-FAPI-46
Ga-68-FAPI-46 PET scan in colorectal cancer
Primary outcome measures
- Sensitivity, Specificity, and Accuracy of Ga-68-FAPI-46 PET for CRC Recurrence Detection [Time frame: Within 6 months of PET imaging.]
- Comparison of Ga-68-FAPI-46 PET and FDG PET in CRC Recurrence Detection [Time frame: Within 6 months of PET imaging.]
Secondary outcome measures (1)
- Clinical Impact of Ga-68-FAPI-46 PET on Management Decisions [Time frame: Immediately after completion of PET imaging and report review.]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Taiwan · 1 center
- Koo Foundation Sun Yat-Sen Cancer Center — Taipei
Identifiers
NCT: NCT06769828 · KF-FAPI46-001