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NCT Number: 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)

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)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic accuracy

    Time frame: Baseline and up to 3 months

    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.

  2. Standardized uptake value(SUV)

    Time frame: Baseline and up to 3 months

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

  3. Target-to-background ratio(TBR)

    Time frame: Baseline and up to 3 months

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

Secondary outcomes

  1. Progress free survival

    Time frame: 3 years

    Progress free survival

  2. Overall survival

    Time frame: 3 years

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Jiajia Hu

CONTACT

[email protected]

13524945287

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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