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

Completed

• Conditions: CD34 Selected Peripheral Blood Stem Cell Graft
• Interventions: Device: PET/CT scans; Device: MRI

• Registration Number: NCT02909075
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-21
• Status Verified: 2020-01
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PET/CT scans and MRI	PET/CT scans	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.
PET/CT scans and MRI	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.

Primary Outcome Measures

Name	Time	Method
change in thymic size	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.

Trial Locations

Locations (3)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan-Kettering Cancer Center at Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States