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)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Eligible inpatients and outpatients from Ruijin Hospital

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: Patients diagnosis of advanced colorectal cancer

Trial outcomes

Primary outcomes

1

Diagnostic accuracy

18F-FDG and 68Ga-FAPI PET/CT was used to diagnose the lesions of the patients, and the diagnostic performance of PET/CT was evaluated by comparing the diagnostic results with the pathological results/clinical evaluation results.

Time frame
Baseline and up to 3 months
2

Standardized uptake value(SUV)

SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for tumor lesions

Time frame
Baseline and up to 3 months
3

Target-to-background ratio(TBR)

68Ga-FAPI and 18F-FDG uptake ratio of tumor lesions to mediastinum and liver blood pool on PET/CT images.

Time frame
Baseline and up to 3 months

Secondary outcomes

1

Progress free survival

Progress free survival

Time frame
3 years
2

Overall survival

Overall survival

Time frame
3 years

Other outcomes

Sponsors and contacts

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