Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA
ConditionColorectal Cancer Recurrent
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-100
SponsorKoo Foundation Sun Yat-Sen Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Already performed or scheduled for FDG PET scanning examination. (5) Able to lie flat for at least 30 minutes.
Signing the subject consent form.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Ga-68-FAPI-46
DrugGa-68-FAPI-46 PET scan in colorectal cancer
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Ga-68-FAPI-46 PET scan in colorectal cancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 6 months of PET imaging.2
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.
Time frame
Within 6 months of PET imaging.Secondary outcomes
1
Clinical Impact of Ga-68-FAPI-46 PET on Management Decisions
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.
Time frame
Immediately after completion of PET imaging and report review.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov