Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
3 participants
OBSERVATIONAL
2018-08-16
2020-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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Brown Adipose Tissue Positive patients
Patients with known malignancy and incidental finding of positron emission tomography/ computerized tomography (PET/CT) scans positive for brown adipose tissue (BAT). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room.
Resting Energy Expenditure
During each visit, the participant will be assessed in a resting state in a stable temperature controlled environment, and will undergo tests to find out how the body adjusts its metabolism to different temperatures.
Thermal Comfort Questionnaire
Patients will be given a questionnaire to assess their thermal response (whether they felt warmer or colder) during each study visit.
Brown Adipose Tissue Negative Patients
Patients with known malignancy and no evidence of brown adipose tissue BAT activity positron emission tomography/ computerized tomography (PET/CT) scans to be matched to group 1 for primary tumor and stage, sex, age (±5 years), BMI (±3 Kg/m2). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room.
Resting Energy Expenditure
During each visit, the participant will be assessed in a resting state in a stable temperature controlled environment, and will undergo tests to find out how the body adjusts its metabolism to different temperatures.
Thermal Comfort Questionnaire
Patients will be given a questionnaire to assess their thermal response (whether they felt warmer or colder) during each study visit.
Interventions
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Resting Energy Expenditure
During each visit, the participant will be assessed in a resting state in a stable temperature controlled environment, and will undergo tests to find out how the body adjusts its metabolism to different temperatures.
Thermal Comfort Questionnaire
Patients will be given a questionnaire to assess their thermal response (whether they felt warmer or colder) during each study visit.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have active cancer diagnosis.
* Have had a PET/CT scan within the past 12 months at time of enrollment.
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Women who are pregnant or unsure of their pregnancy status
* Women who are breastfeeding
* Suffers from severe claustrophobia
* Diagnosed with a serious psychiatric condition which could impede the judgement of the investigators, and/or the successful conduct of the recording.
* In remission stage for cancer diagnosis
40 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Francesco S Celi, MD, MHSc
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University/ Massey Cancer Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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NCI-2018-01510
Identifier Type: OTHER
Identifier Source: secondary_id
HM20009089
Identifier Type: OTHER
Identifier Source: secondary_id
MCC-17-13470
Identifier Type: -
Identifier Source: org_study_id
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