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)

NCT06601075 | Recruiting DMC

• 1 other identifier: RuijinH 2024-80
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Advanced Colorectal Cancer

Keywords

68Ga-FAPI PET/CT; diagnosis; advanced colorectal cancer; efficacy evaluation

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and up to 3 months

• Standardized uptake value(SUV)

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

  Baseline and up to 3 months

• 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.

  Baseline and up to 3 months

Secondary Outcomes (2)

• Progress free survival

  3 years

• Overall survival

  3 years

Study Arms (1)

Patients diagnosis of advanced colorectal cancer

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible inpatients and outpatients from Ruijin Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jiajia Hu

CONTACT

13524945287; jiajiahu@shsmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 19, 2024
• Study Start: February 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2029
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)