- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05577299
Factors Affecting BAT Activation in PET/CT
October 9, 2022 updated by: Mona Nabil Helbawi, Assiut University
Factors Affecting Brown Adipose Tissue (BAT) Activation in Cancer Patients Undergoing 18F-FDG-PET/CT
The aim of the present study is to evaluate the factors affecting BAT activation in 18F-FDG-PET/CT in different tumours
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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
Study Type
Observational
Enrollment (Anticipated)
80
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
cancer patients undergoing PET/CT
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the main factors that affect appearance of BAT in PET/CT studies and try to avoid these factors.
Time Frame: from 7/2019 to 7/2022
|
the amount and SUV max of the detected BAT activation in PET scan correlated with the patient prognosis.
|
from 7/2019 to 7/2022
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
November 1, 2022
Primary Completion (ANTICIPATED)
August 1, 2025
Study Completion (ANTICIPATED)
October 1, 2025
Study Registration Dates
First Submitted
October 9, 2022
First Submitted That Met QC Criteria
October 9, 2022
First Posted (ACTUAL)
October 13, 2022
Study Record Updates
Last Update Posted (ACTUAL)
October 13, 2022
Last Update Submitted That Met QC Criteria
October 9, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- BAT activation in PET/CT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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