Factors Affecting BAT Activation in PET/CTNCT05577299
Factors Affecting BAT Activation in PET/CT
An observational study of Factors Affecting BAT Activation in PET/CT, run by Assiut University.
Trial summary
The aim of the present study is to evaluate the factors affecting BAT activation in 18F-FDG-PET/CT in different tumours Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Factors Affecting BAT Activation in PET/CT
- What is being tested?
- PET/CT
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Adult, Older adult
Study population: cancer patients undergoing PET/CT
Who may be able to join
- This study will include all patients presented with different types of tumors.
- patients conscious to provide informed consent
Who cannot join
- • 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
About this study
Official title: 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
Read the 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
- Being tested
- PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from 7/2019 to 7/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Factors Affecting BAT Activation in PET/CTStudies 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
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Nabil Helbawi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577299
- Sponsor's protocol ID
- BAT activation in PET/CT
- Status last verified
- Sep 2022
- First submitted
- 9 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Brown Adipose Tissue (BAT) Activation in Cancer Patients Undergoing 18F-FDG-PET/CT
- ClinicalTrials.gov ID
- NCT05577299
- Acronym / sponsor ID
- BAT activation in PET/CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 13 Oct 2022 (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.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- cancer patients undergoing PET/CT
Key inclusion criteria (2 listed)
- This study will include all patients presented with different types of tumors.
- patients conscious to provide informed consent
Key exclusion criteria (3 listed)
- • Patients who have contraindications to PET/CT scanning such as: a blood glucose level higher than 150-200 mg/dL, uncontrolled diabetics.
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 |
|---|---|---|
| PET/CT18F-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. | Device | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Factors Affecting BAT Activation in PET/CT, 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 3 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2022.