Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA
Recruiting · NCT06769828 · Interventional (participants receive a specific treatment) · Lead sponsor: Koo Foundation Sun Yat-Sen Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Ga-68-FAPI-46
What this trial is about
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.
Who can take part
Age range
20 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed.
- Koo Foundation Sun Yat-Sen Cancer Center - Taipei, Beitou, Taiwan