Role of Positron Emission Tomography in Detecting Primary... | NCT06086652

Studies
Role of Positron Emission Tomography in Detecting Primary Tumor in Cases of Metastases of Unknown Origin

NCT06086652

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Oct 17, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Metastasis of Unknown Origin

Interventions

PET/CT

Countries

Egypt

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2023Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Oct 11, 2023

First Submission Date that Met QC Criteria

Oct 11, 2023

First Posted Date

Oct 17, 2023Actual

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

Oct 11, 2023

Last Update Posted Date

Oct 17, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Doaa Ibrahim Mohamed, lecturer of nuclear medicine, faculty of medicine, Sohag university, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In most cases of malignancies, the site of origin of the cancer is clear at presentation or identified soon after. However, Metastatic cancer of unknown primary site (MUO) accounts for 3-5% of all malignant neoplasms, and it is defined as metastatic cancer from an unknown primary site, for which no original site can be detected even after performing all possible tests. Most common metastatic sites include the liver, lymph nodes, lungs, and bones.

18F-fluoro-2-deoxyglucose positron emission tomography (FDG-PET) allows whole-body tumor detection and has proven to be useful in patients with metastasis of unknown primary tumor.

Detailed Description

Not provided

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

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET/CT	Diagnostic Test	detection of possible primary tumor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
primary tumor for metastasis of unknown origin	primary tumor for metastasis of unknown origin	one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years Patients with metastatic tumor. Primary site was not detected with other radiological examinations Both male and female.

Exclusion Criteria:

Patients with known primary tumor Pregnancy. Age < 18 years.

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

Age > 18 years Patients with metastatic tumor. Primary site was not detected with other radiological examinations Both male and female.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Doaa I Mohamed, lecturer	Contact	01007779485		doaaibrahim@med.soh.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag university Hospital	Recruiting	Sohag			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36435296	Background	van der Strate I, Kazemzadeh F, Nagtegaal ID, Robbrecht D, van de Wouw A, Padilla CS, Duijts S, Esteller M, Greco FA, Pavlidis N, Qaseem A, Snaebjornsson P, van Zanten SV, Loef C. International consensus on the initial diagnostic workup of cancer of unknown primary. Crit Rev Oncol Hematol. 2023 Jan;181:103868. doi: 10.1016/j.critrevonc.2022.103868. Epub 2022 Nov 23.
18925401

ID	Term
D049268	Positron-Emission Tomography
D014055	Tomography, Emission-Computed
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging