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)
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Advanced Colorectal Cancer. Basic parameters: from 18 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
- China
- 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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Overview
This study aims to investigate the value of 18F-FDG and 68Ga-FAPI PET/CT in evaluating the outcome of conversion therapy and the prognosis of advanced colorectal cancer (peritoneal metastasis with/without other metastases)
Detailed description
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo 18F-FDG and 68Ga-FAPI PET/CT at baseline and after 3 months of conversion therapy. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.
Primary outcome measures
- Diagnostic accuracy [Time frame: Baseline and up to 3 months]
- Standardized uptake value(SUV) [Time frame: Baseline and up to 3 months]
- Target-to-background ratio(TBR) [Time frame: Baseline and up to 3 months]
Secondary outcome measures (2)
- Progress free survival [Time frame: 3 years]
- Overall survival [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Histologically confirmed colorectal cancer, clinical or other imaging suspicion of peritoneal metastasis with or without other distant metastases.
- Patients voluntarily enrolled in this study by signing an informed consent form
- Age ≥ 18 years
- Expected life expectancy ≥ 3 months
- Adequate organ and bone marrow function
- Willingness to adhere to the study protocol and follow-up programme
Exclusion criteria
- Pregnant or breastfeeding women.
- Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and carcinoma in situ of cervix
- Severe mental disease, uncontrolled epilepsy, or central nervous system disease
- Subjects with current concurrent interstitial pneumonitis or interstitial lung disease, or subjects with previous interstitial pneumonitis or interstitial lung disease requiring hormonal therapy, or subjects with other conditions that may interfere with the judgement and management of immune-related pulmonary toxicity, e.g., pulmonary fibrosis, organising pneumonia (e.g., occlusive bronchiectasis), pulmonary fibrosis, organising pneumonia (e.g., occlusive bronchiectasis), pneumoconiosis, Drug-associated pneumonia, idiopathic pneumonia, active pneumonia, or severe pulmonary impairment on CT; and active tuberculosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine — Shanghai
Identifiers
NCT: NCT06601075 · RuijinH 2024-80