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RecruitingNCT06601075Updated Jan 22, 2025

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)

An observational study in Advanced Colorectal Cancer, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by Ruijin Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Advanced Colorectal Cancer

Keywords

  • 68Ga-FAPI PET/CT
  • diagnosis
  • advanced colorectal cancer
  • efficacy evaluation
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 30 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Eligible inpatients and outpatients from Ruijin Hospital

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Patients diagnosis of advanced colorectal cancer

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
    Shanghai, Shanghai 200025, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06601075
Lead sponsor
Ruijin Hospital
Responsible party
Hu Jiajia (Deputy director, Ruijin Hospital) — Principal investigator
First posted
Sep 19, 2024
Start date
Feb 1, 2025 (estimated)
Primary completion
Mar 31, 2026 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Jan 22, 2025

Study contacts

Jiajia Hu
Contact
jiajiahu@shsmu.edu.cn
13524945287

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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