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NCT Number: NCT06597526

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

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.

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

Zhongyin Yang

CONTACT

[email protected]

0086-13564877661

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Signs of distant metastases other than peritoneal metastases at enrolment
  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  3. 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.

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.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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