The Role of 18F-FDG&68Ga-FAPI PET/CT in the Assessmen... | NCT06597526

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

NCT06597526

Sponsor

Ruijin Hospital

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Peritoneal Metastasis
Gastric Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2024Actual

Primary Completion Date

Mar 31, 2028Estimated

Completion Date

May 31, 2029Estimated

First Submitted Date

Sep 10, 2024

First Submission Date that Met QC Criteria

Sep 13, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
gastric cancer patients with peritoneal metastasis		Initial diagnosis of gastric cancer with peritoneal metastases, excluding other distant metastases

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline, preoperative assessment and time of postoperative recurrence assessment
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	Baseline, preoperative assessment and time of postoperative recurrence assessment
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.	Baseline and preoperative assessment

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Eligible inpatients and outpatients from Ruijin Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiajia Hu	Contact	0086-13524945287		jiajiahu@shsmu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine	Recruiting	Shanghai	Shanghai Municipality	200025	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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