- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05687552
Role of 18F-FDG PET/CT in Gastric Cancer
Study Overview
Detailed Description
gastric cancer (GC) is the fifth most common malignancy and the third leading cause of cancer mortality worldwide (1) It carries a poor prognosis, with a 5-year survival of only 20%-30% (2) Clinical staging, based mainly on imaging, is critical in determining the best treatment.There is a widely accepted consensus of the usefulness of FDG PET/CT in staging and restaging of gastric cancer. According to evidence-based data, this modality can evaluate gastric cancer more accurately and is helpful for evaluation of tumor biologic characteristics, detection of lymph node and distant metastases, assessment of tumor response to therapy(9).
retrospective and prospective study will conducted at Sohag oncology hospital, nuclear medicine unit& Assuit university hospital, nuclear medicine unit including 50 patients in 12 months .
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: sara saber, ass lec
- Phone Number: 01097661576
- Email: jasmenahmed90@gmail.com
Study Contact Backup
- Name: waleed diab, ass prof
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients diagnosed as GC on surgically resected specimens;
- Patients with gastric and extragastric metastasis.
- patients with gastric cancer either operated or not.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
comparison of pet -ct finding with ct finding
Time Frame: base line
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: wafaa elmaghraby, ass prof, Sohag University
- Study Director: mohamed soliman, prof, Sohag University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- gastric cancer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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