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)

NCT ID: NCT06601075

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2029-03-31

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.

Conditions

Advanced Colorectal Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients diagnosis of advanced colorectal cancer

Patients diagnosis of advanced colorectal cancer (peritoneal metastasis with/without other metastases)

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hu Jiajia

Deputy director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiajia Hu

Role: CONTACT

jiajiahu@shsmu.edu.cn

13524945287

Facility Contacts

Hao Li

Role: primary

rj11001@rjh.com.cn

15000660260

Other Identifiers

RuijinH 2024-80

Identifier Type: -

Identifier Source: org_study_id