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

September 13, 2024 updated by: Hu Jiajia, Ruijin Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Eligible inpatients and outpatients from Ruijin Hospital

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
gastric cancer patients with peritoneal metastasis
Initial diagnosis of gastric cancer with peritoneal metastases, excluding other distant metastases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target-to-background ratio(TBR)
Time Frame: Baseline, preoperative assessment and time of postoperative recurrence assessment
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.
Baseline, preoperative assessment and time of postoperative recurrence assessment
Standardized uptake value(SUV)
Time Frame: Baseline, preoperative assessment and time of postoperative recurrence assessment
SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric lesions, peritoneal lesions and recurrent metastatic lesions
Baseline, preoperative assessment and time of postoperative recurrence assessment
Evaluation the outcome of conversion therapy
Time Frame: Baseline and preoperative assessment
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.
Baseline and preoperative assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
Overall survival
3 years
Progress free survival
Time Frame: 3 years
Progress free survival
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2024

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

May 31, 2029

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 13, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 13, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RuijinH 2024-93

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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