Gastric CancerNCT05687552
Role of 18F-FDG PET/CT in Gastric Cancer
An observational study of Gastric Cancer, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- pet -ct
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: patient diagnosed by pathology as gastric cancer
Who may be able to join
- patients diagnosed as GC on surgically resected specimens;
- Patients with gastric and extragastric metastasis.
- patients with gastric cancer either operated or not.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
waleed diab, ass prof contact
About this study
The objective of the study is to assess the value of PET/CT in diagnosis, staging, response evaluation, and relapse monitoring of gastric cancer.
Read the 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 .
- Conditions
- Gastric Cancer
- Being tested
- pet -ct
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pet -ctDevice
assessment of added value of pet -ct in patients with gastric cancer and how patient get benefit from this finding
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Saber Ahmed, Sohag University
- Investigators
- wafaa elmaghraby, ass prof, Study director, Sohag Universitymohamed soliman, prof, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687552
- Sponsor's protocol ID
- gastric cancer
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31392480Saka 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.
PubMed 19132483Liu 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.
PubMed 34589429
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of 18F-FDG PET/CT in Gastric Cancer
- ClinicalTrials.gov ID
- NCT05687552
- Acronym / sponsor ID
- gastric cancer
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to assess the value of PET/CT in diagnosis, staging, response evaluation, and relapse monitoring of gastric cancer.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patient diagnosed by pathology as gastric cancer
Key inclusion criteria (3 listed)
- patients diagnosed as GC on surgically resected specimens;
- Patients with gastric and extragastric metastasis.
- patients with gastric cancer either operated or not.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pet -ctassessment of added value of pet -ct in patients with gastric cancer and how patient get benefit from this finding | Device | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Background: PubMed 31392480Tang 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.
- Background: PubMed 19132483Saka 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.
- Results publication: PubMed 34589429Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
waleed diab, ass prof contact
wafaa elmaghraby, ass prof study director
Sohag University
mohamed soliman, prof study director
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara saber, ass lec (01097661576, jasmenahmed90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of pet -ct finding with ct finding (time frame: base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05687552, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.