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A Study to Assess Thymic Function Using PET/CT and MRI

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ClinicalTrials.gov Identifier: NCT02909075
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
CD34 Selected Peripheral Blood Stem Cell Graft Device: PET/CT scans Device: MRI

Study Design
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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Initial Study of FDG-PET/CT and MRI to Assess Thymic Function
Study Start Date : August 2016
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

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Groups and Cohorts
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Group/Cohort Intervention/treatment
PET/CT scans and MRI
Eligible patients will be enrolled onto the study, and will undergo 3 limited field of view (FOV) FDG-PET/CT scans and MRI of the chest: at baseline (within 4 weeks prior to transplantation), and approximately 3 months (+/-2 weeks) and 6 months (+/-2 weeks) after transplant. PET/CT and MR imaging can be completed on the same day. We will also offer the exams on other days if this is easier for the patient. The PET/CT and MR should be performed within 2 weeks of each other.
 Device: PET/CT scans
Device: MRI


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MSK BMT clinic
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909075


Locations
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United States, New Jersey
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Heiko Schoder, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02909075    
Other Study ID Numbers: 16-1244
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
PET/CT
MRI
Assess Thymic Function
16-1244