NCT Number: NCT02909075
A Study to Assess Thymic Function Using PET/CT and MRI
The purpose of this study is to see if a positron emission tomography/computed tomography (PET/CT) scan and a magnetic resonance imaging (MRI) of the chest can assess changes in the thymus size and function. The researchers would like to monitor the thymus with a PET/CT scan and a MRI before and after the participants transplantation.
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Notify MeKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Memorial Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patient's age is ≥18 or ≤65 years old.
- Patients must have a plan to receive a CD34-selected peripheral blood stem cell graft.
Exclusion criteria
- Patient is not able to undergo MR imaging due to any contraindication to MRI based on departmental MR questionnaire (e.g. past gadolinium allergies, failure of metallic screening, claustrophobia, inability to lay flat for duration of the study, inability to hold breath, etc.)
- Pregnant or breastfeeding.
Treatment and study plan
MRI
DevicePrimary outcomes
-
change in thymic size
Time frame: 1 year
A clinically meaningful change is defined as increase in thymic size (> 0.2cm increase in uni-dimensional diameter), functional volume (>10%) or uptake (≥25%). We will report proportion of patients with each component of clinically meaningful change, as well as the proportion with at least one component, along 95% exact confidence intervals.
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Registry information
Official study title
An Initial Study of FDG-PET/CT and MRI to Assess Thymic Function
Important dates
- Study start
- 2016
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Sep 21, 2016
- Registry last updated
- Jan 27, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.