Clinical trial NCT06601075: 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)
Official 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Colorectal Cancer
Keywords: 68Ga-FAPI PET/CT
diagnosis
advanced colorectal cancer
efficacy evaluation
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible inpatients and outpatients from Ruijin Hospital

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed colorectal cancer, clinical or other imaging suspicion of peritoneal metastasis with or without other distant metastases.
2. Patients voluntarily enrolled in this study by signing an informed consent form
3. Age ≥ 18 years
4. Expected life expectancy ≥ 3 months
5. Adequate organ and bone marrow function
6. Willingness to adhere to the study protocol and follow-up programme

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and carcinoma in situ of cervix
3. Severe mental disease, uncontrolled epilepsy, or central nervous system disease
4. 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

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: Baseline and up to 3 months
measure: Standardized uptake value(SUV)
timeFrame: Baseline and up to 3 months
measure: Target-to-background ratio(TBR)
timeFrame: Baseline and up to 3 months
Secondary outcomes:
measure: Progress free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
state: Shanghai
Study officials:
References: