F-18 FDG PET/CT and CT in Initial Staging of Non-small Lu... | NCT06789562

Studies
F-18 FDG PET/CT and CT in Initial Staging of Non-small Lung Cancer

NCT06789562

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Jan 23, 2025Actual

Enrollment

54Estimated

Phase

Not provided

Conditions

Lung Cancer

Interventions

F-18FDG PET/CT and CT

Countries

Not provided

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

Jan 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2025Estimated

Primary Completion Date

Nov 30, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jan 18, 2025

First Submission Date that Met QC Criteria

Jan 22, 2025

First Posted Date

Jan 23, 2025Actual

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

Jan 22, 2025

Last Update Posted Date

Jan 23, 2025Actual

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
F-18FDG PET/CT and CT	Device	compare F-18 FDG PET/CT to routine CT in staging of non-small lung cancer and effect on change management.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 .	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with pathologically proven NSCLC who underwent initial PET/CT images.
All patients ≥ 18 years.

Exclusion Criteria:

Patients who had started treatment before initial PET/CT. Patients with glucose level < 200 mg/dl. Patients with another malignant condition.

Accepts Healthy Volunteers

Not provided

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

adult patients with non small lung cancer underwent initial F-18FDG PET/CT

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Walaa Gamal, assistant lecturer	Contact	01065037395		dr.walaa196@gmail.com
Nahla Moustafa, assistant professor	Contact	01009466255		Nahla_bashank_2006@yahoo.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3493	Background	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.

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms