Lung CancerNCT06789562
F-18 FDG PET/CT and CT in Initial Staging of Non-small Lung Cancer
An observational study of Lung Cancer, run by Assiut University.
Trial summary
Is to compare F-18 FDG PET/CT to routine CT in staging of non-small lung cancer and effect on change management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- F-18FDG PET/CT and CT
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: adult patients with non small lung cancer underwent initial F-18FDG PET/CT
Who may be able to join
- Patients with pathologically proven NSCLC who underwent initial PET/CT images.
- All patients ≥ 18 years.
Who cannot join
- Patients who had started treatment before initial PET/CT. Patients with glucose level < 200 mg/dl. Patients with another malignant condition.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of F-18 FDG PET/CT and CT in Initial Staging of Non-small Lung Cancer
Is to compare F-18 FDG PET/CT to routine CT in staging of non-small lung cancer and effect on change management.
Read the detailed description
- The optimal treatment of non-small cell lung cancer (NSCLC) relies on accurate disease staging that is based on the TNM system which relies on tumor size, regional nodal involvement, and the presence of metastasis.
- CT is the standard modality used to assess the intra-thoracic spread but false negative CT scans have been reported and were related to the presence of metastasis in normal sized lymph nodes and false positive findings have been related to lymph node enlargement due to benign process.
PET is most widely used in thoracic oncology because of its superiority over other imaging techniques in staging nodal and metastatic disease, however, the poor anatomic details of PET can lead to errors in diagnosis and staging.
- To solve this problem, CT is combined with PET to provide matched morphological and functional data. The diagnostic capability of PET/CT in the preoperative staging of lung cancer is superior to that of CT alone and PET alone as it has the advantage of a more accurate assignment of tumor stage (T stage) and defining the lymph node stage (N stage) as well as reduction of the number of useless thoracotomies
- Conditions
- Lung Cancer
- Being tested
- F-18FDG PET/CT and CT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18FDG PET/CT and CTDevice
compare F-18 FDG PET/CT to routine CT in staging of non-small lung cancer and effect on change management.
What is being measured
The primary outcome is the main question the study is designed to answer.
compare F-18 FDG PET/CT to routine CT in staging of non-small lung cancer and effect on change management.
detect added value of F-18FDG PET/CT .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start30 Jan 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Gamal Fathy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789562
- Sponsor's protocol ID
- F-18 FDG PET/CTand CT in lung
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
Publications
Hadar R, Slonim A, Kuhn J. Role of D-tryptophan oxidase in D-tryptophan utilization by Escherichia coli. J Bacteriol. 1976 Mar;125(3):1096-1104. doi: 10.1128/jb.125.3.1096-1104.1976.
PubMed 3493
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of F-18 FDG PET/CT and CT in Initial Staging of Non-small Lung Cancer
- ClinicalTrials.gov ID
- NCT06789562
- Acronym / sponsor ID
- F-18 FDG PET/CTand CT in lung
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jan 2025 (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.
Is to compare F-18 FDG PET/CT to routine CT in staging of non-small lung cancer and effect on change management.
Detailed description
- The optimal treatment of non-small cell lung cancer (NSCLC) relies on accurate disease staging that is based on the TNM system which relies on tumor size, regional nodal involvement, and the presence of metastasis.
- CT is the standard modality used to assess the intra-thoracic spread but false negative CT scans have been reported and were related to the presence of metastasis in normal sized lymph nodes and false positive findings have been related to lymph node enlargement due to benign process.
PET is most widely used in thoracic oncology because of its superiority over other imaging techniques in staging nodal and metastatic disease, however, the poor anatomic details of PET can lead to errors in diagnosis and staging.
- To solve this problem, CT is combined with PET to provide matched morphological and functional data. The diagnostic capability of PET/CT in the preoperative staging of lung cancer is superior to that of CT alone and PET alone as it has the advantage of a more accurate assignment of tumor stage (T stage) and defining the lymph node stage (N stage) as well as reduction of the number of useless thoracotomies
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patients with non small lung cancer underwent initial F-18FDG PET/CT
Key inclusion criteria (2 listed)
- Patients with pathologically proven NSCLC who underwent initial PET/CT images.
- All patients ≥ 18 years.
Key exclusion criteria (1 listed)
- Patients who had started treatment before initial PET/CT. Patients with glucose level < 200 mg/dl. Patients with another malignant condition.
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 |
|---|---|---|
| F-18FDG PET/CT and CTcompare F-18 FDG PET/CT to routine CT in staging of non-small lung cancer and effect on change management. | Device | – |
Primary outcome
compare F-18 FDG PET/CT to routine CT in staging of non-small lung cancer and effect on change management.
Time frame: Baseline
detect added value of F-18FDG PET/CT .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Background: PubMed 3493Hadar R, Slonim A, Kuhn J. Role of D-tryptophan oxidase in D-tryptophan utilization by Escherichia coli. J Bacteriol. 1976 Mar;125(3):1096-1104. doi: 10.1128/jb.125.3.1096-1104.1976.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Assiut 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 23 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walaa Gamal, assistant lecturer (01065037395, dr.walaa196@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare F-18 FDG PET/CT to routine CT in staging of non-small lung cancer and effect on change management. (time frame: Baseline). 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 NCT06789562, which also lists 1 linked publication.
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 23 Jan 2025.