Factors Affecting BAT Activation in PET/CT | NCT05577299

Studies
Factors Affecting BAT Activation in PET/CT

NCT05577299

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Oct 13, 2022Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Factors Affecting BAT Activation in PET/CT

Interventions

PET/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

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Estimated

Primary Completion Date

Aug 1, 2025Estimated

Completion Date

Oct 1, 2025Estimated

First Submitted Date

Oct 9, 2022

First Submission Date that Met QC Criteria

Oct 9, 2022

First Posted Date

Oct 13, 2022Actual

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 9, 2022

Last Update Posted Date

Oct 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The aim of the present study is to evaluate the factors affecting BAT activation in 18F-FDG-PET/CT in different tumours

Detailed Description

Positron emission tomography (PET)/CT with fluorine-18 fluorodeoxyglucose (18F-FDG) is currently a standard diagnostic tool for identifying tumours and their metastases as well as infectious or inflammatory lesions.1-3 High physiological uptake of 18F-FDG is found in organs with high glucose metabolism, such as the brain and heart. One particular tissue with high 18F-FDG uptake that can interfere with scan interpretation is brown fat.4 Brown fat, or brown adipose tissue (BAT), is involved in non-shivering thermogenesis and creates heat through glucose metabolism. It is found mostly in the cervical, supraclavicular and thoracic paravertebral regions,5 and some is also found in the axillae, mediastinum and abdomen.6 Although it is usually simple for nuclear medicine physicians to recognize BAT uptake through its typical pattern and from the low attenuation in the CT scan, high uptake in BAT can still be mistaken for a malignant lesion or cause false-negative results by obscuring small metastases and decrease diagnostic confidence of the scan professional reading. BAT has a preferential distribution over the body and a preferential occurrence in female, younger and thinner patients. It mainly interferes with scan interpretation in tumours that occurs at younger age and is located in or metastasize to the head, neck and peri clavicular/axillary regions, such as melanoma of the upper body, breast cancer, and head and neck cancers, but it can also cause problems in lung and other cancers.7.8

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

80Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET/CT	Device	18F-fluorodeoxyglucose positron emission tomography/computed tomography (18FFDG PET/CT) is a non-invasive imaging modality used for staging and surveillance of various types of malignancies through imaging of glucose metabolism in cancer cells.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the main factors that affect appearance of BAT in PET/CT studies and try to avoid these factors.	the amount and SUV max of the detected BAT activation in PET scan correlated with the patient prognosis.	from 7/2019 to 7/2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

This study will include all patients presented with different types of tumors.
patients conscious to provide informed consent

Exclusion Criteria:

• Patients who have contraindications to PET/CT scanning such as: a blood glucose level higher than 150-200 mg/dL, uncontrolled diabetics.
- Intolerance of PET/CT due to claustrophobia will be excluded from the study.
- Patients under age of 18

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

cancer patients undergoing PET/CT

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D000072078	Positron Emission Tomography Computed Tomography

Ancestor Terms

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

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