Actively Recruiting
The Role of 18F-FDG and 68Ga-FAPI PET/CT in the Diagnosis and Efficacy Evaluation of Advanced Colorectal Cancer with Peritoneal Metastasis
Led by Ruijin Hospital · Updated on 2025-01-22
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of two imaging methods, 18F-FDG and 68Ga-FAPI PET/CT scans, to assess the treatment response and outlook for people with advanced colorectal cancer that has spread to the peritoneum, with or without other metastases. This observational study aims to compare these imaging results with standard clinical or pathological assessments to understand their value in managing this cancer type. All participants will receive both 18F-FDG and 68Ga-FAPI PET/CT scans at the beginning of the study and again after 3 months of conversion therapy, a treatment approach intended to make tumors operable or manageable. The study will track measurements such as diagnostic accuracy, standardized uptake values, and target-to-background ratios from these scans over this period. Participants will have their basic information and medical history recorded before the scans. The study will monitor outcomes like progression-free survival and overall survival for up to 3 years. Researchers will evaluate imaging results alongside clinical follow-up information to determine how well these scans predict treatment effectiveness and patient prognosis.
CONDITIONS
Brief Title
The Role of 18F-FDG and 68Ga-FAPI PET/CT in the Diagnosis and the Efficacy Evaluation of Advanced Colorectal Cancer (peritoneal Metastasis With/without Other Metastases)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colorectal cancer with clinical or imaging suspicion of peritoneal metastasis with or without other distant metastases
- Voluntary enrollment with signed informed consent
- Age 18 years or older
- Expected life expectancy of at least 3 months
- Adequate organ and bone marrow function
- Willingness to follow the study protocol and attend follow-up visits
You will not qualify if you...
- Pregnant or breastfeeding women
- History of other malignant diseases in the last 5 years except cured skin cancer and carcinoma in situ of cervix
- Severe mental illness, uncontrolled epilepsy, or central nervous system disease
- Current or previous interstitial pneumonitis or interstitial lung disease requiring hormonal therapy
- Other lung conditions that may affect immune-related pulmonary toxicity assessment, including pulmonary fibrosis, organising pneumonia, pneumoconiosis, drug-associated pneumonia, idiopathic pneumonia, active pneumonia, severe pulmonary impairment on CT, or active tuberculosis
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline and after 3 months
Participants undergo 18F-FDG and 68Ga-FAPI PET/CT imaging to assess advanced colorectal cancer with peritoneal metastasis.
2 imaging visits (in-person)
Duration - Up to 3 years
Participants are monitored for progression-free survival and overall survival for up to 3 years.
Follow-up visits as scheduled for up to 3 years
Trial Site Locations
Total: 1 location
1
Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
J
Jiajia Hu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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