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RecruitingNCT06597526Updated Sep 19, 2024

The Role of 18F-FDG&68Ga-FAPI PET/CT in the Assessment of Conversion Therapy Efficacy in Gastric Cancer with Peritoneal Metastasis.

An observational study in Peritoneal Metastasis and Gastric Cancer, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Ruijin Hospital · Observational

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 3 months later.
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\&68Ga-FAPI PET/CT in evaluating the outcome of conversion therapy and the prognosis of people with peritoneal metastases from gastric cancer.

Read the detailed description

If the target population of the study agrees to participate in the study, we will number the participants, resume their pathology files, and collect their gender, age, phone number, height and weight information, record the participants\' consultation process and the results of the tests and examinations therein. During the course of the study we will perform 18F-FDG \& 68Ga-FAPI PET/CT according to the participant\'s stage of disease, specifically: one 18F-FDG PET/CT prior to conversion therapy and one 68Ga-FAPI PET/CT as a baseline assessment. One 18F-FDG PET/CT and one 68Ga-FAPI PET/CT were performed before the clinician assessed that the conversion therapy was ready to be completed and the conversion surgery was about to be performed, and if the participant experienced a postoperative recurrence of the disease during the study period, another 18F-FDG PET/CT and a 68Ga-FAPI PET/CT would be performed, meaning that a total of 4 PET/CTs were performed. In other words, a total of 4 PET/CT visualizations were required for all participants; 2 additional PET/CT visualizations, including 18F-FDG PET/CT and 68Ga-FAPI PET/CT, were performed if the disease recurred after the conversion surgery, and none were required for participants without recurrence.

02

Conditions studied

  • Peritoneal Metastasis
  • Gastric Cancer

Keywords

  • 18F-FDG PET/CT
  • 68Ga-FAPI PET/CT
  • gastric cancer
  • peritoneal metastases
  • conversion therapy
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 30 is below the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis 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 gastric adenocarcinoma with no history of resection of primary or metastatic lesions
  2. Peritoneal metastases of gastric cancer requiring laparoscopy for definitive diagnosis without gastric outflow tract obstruction and intestinal obstruction
  3. Patients voluntarily enrolled in this study by signing an informed consent form
  4. Age ≥ 18 years
  5. Eastern Cooperative Oncology Group (ECOG) score ≤ 2,
  6. Expected life expectancy ≥ 3 months
  7. Adequate organ and bone marrow function
  8. Willingness to adhere to the study protocol and follow-up programme

Exclusion criteria

Exclusion Criteria:

  1. Signs of distant metastases other than peritoneal metastases at enrolment
  2. Pregnant or breastfeeding women.
  3. Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and carcinoma in situ of cervix
  4. Severe mental disease, uncontrolled epilepsy, or central nervous system disease
05

Study design

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

Groups and cohorts

  • gastric cancer patients with peritoneal metastasis

    Initial diagnosis of gastric cancer with peritoneal metastases, excluding other distant metastases

06

What researchers measure

Primary outcomes

  1. Target-to-background ratio(TBR)

    68Ga-FAPI and 18F-FDG uptake ratio of primary gastric lesions, peritoneal lesions and recurrent metastatic lesions to mediastinum and liver blood pool on PET/CT images.

    Time frame: Baseline, preoperative assessment and time of postoperative recurrence assessment

  2. Standardized uptake value(SUV)

    SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric lesions, peritoneal lesions and recurrent metastatic lesions

    Time frame: Baseline, preoperative assessment and time of postoperative recurrence assessment

  3. Evaluation the outcome of conversion therapy

    The value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT in evaluating the outcome of conversion therapy in gastric cancer with peritoneal metastasis.

    Time frame: Baseline and preoperative assessment

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 Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06597526
Lead sponsor
Ruijin Hospital
Responsible party
Hu Jiajia (Nuclear medicine, Ruijin Hospital) — Principal investigator
First posted
Sep 19, 2024
Start date
Jun 15, 2024
Primary completion
Mar 31, 2028 (estimated)
Completion
May 31, 2029 (estimated)
Last update
Sep 19, 2024

Study contacts

Jiajia Hu
Contact
jiajiahu@shsmu.edu.cn
0086-13524945287

Oversight

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

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