NCT06769828Recruiting
Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA
Diagnostic Performances of Ga-68-FAPI-46 PET in CRC Patients with Rising Serum CEA During the Post-treatment Surveillance
Source: ClinicalTrials.gov · Last updated 22 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 6 Jan 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 14 Apr 2026
- Lead sponsor
- Koo Foundation Sun Yat-Sen Cancer Center
- Diseases
- Colorectal cancer
- NCT number
- NCT06769828
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Feb 2025 to the primary completion date, 14 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Simultaneously or previously diagnosed with malignant tumors other than colorectal cancer.
Other illness
- severe renal impairment (eGRF\< 30ml/min)
- Known or suspected allergy to radiopharmaceuticals
- Severe medical conditions (severe disabilities, mental disorders)
Other
- pregnant woman and breastfeeding women
- Inability to undergo the necessary PET scan procedure
- Refusal or unwillingness to sign the informed consent form
Who the study is looking for
- 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.
Age in the registry: 20 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Koo Foundation Sun Yat-Sen Cancer Center Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.