NCT05687552

Brief Summary

The objective of the study is to assess the value of PET/CT in diagnosis, staging, response evaluation, and relapse monitoring of gastric cancer.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 8, 2023

Last Update Submit

January 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • comparison of pet -ct finding with ct finding

    The 18F-FDG PET/CT scan is visually estimated in the patients included in the study and quantitatively assessed by estimation of standardized uptake value(suv max). Statistical analysis of the included quantitative data.

    base line

Interventions

pet -ctDEVICE

assessment of added value of pet -ct in patients with gastric cancer and how patient get benefit from this finding

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient diagnosed by pathology as gastric cancer

You may qualify if:

  • patients diagnosed as GC on surgically resected specimens;
  • Patients with gastric and extragastric metastasis.
  • patients with gastric cancer either operated or not.

You may not qualify if:

  • Patients with second malignancy.
  • Patient without proven pathology of cancer stomach.
  • Severely ill patient (patient with disturbed conscious level, or couldn't lay supine during the imaging).
  • uncontrolled diabetic patient with blood glucose level more than 200mg\\dl.
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Tang L, Wang XJ, Baba H, Giganti F. Gastric cancer and image-derived quantitative parameters: Part 2-a critical review of DCE-MRI and 18F-FDG PET/CT findings. Eur Radiol. 2020 Jan;30(1):247-260. doi: 10.1007/s00330-019-06370-x. Epub 2019 Aug 7.

    PMID: 31392480BACKGROUND
  • Saka M, Katai H, Fukagawa T, Nijjar R, Sano T. Recurrence in early gastric cancer with lymph node metastasis. Gastric Cancer. 2008;11(4):214-8. doi: 10.1007/s10120-008-0485-4. Epub 2009 Jan 8.

    PMID: 19132483BACKGROUND
  • Liu Q, Li J, Xin B, Sun Y, Feng D, Fulham MJ, Wang X, Song S. 18F-FDG PET/CT Radiomics for Preoperative Prediction of Lymph Node Metastases and Nodal Staging in Gastric Cancer. Front Oncol. 2021 Sep 13;11:723345. doi: 10.3389/fonc.2021.723345. eCollection 2021.

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • wafaa elmaghraby, ass prof

    Sohag University

    STUDY DIRECTOR
  • mohamed soliman, prof

    Sohag University

    STUDY DIRECTOR

Central Study Contacts

sara saber, ass lec

CONTACT

waleed diab, ass prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 18, 2023

Study Start

January 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share