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

January 24, 2020 updated by: Memorial Sloan Kettering Cancer Center

An Initial Study of FDG-PET/CT and MRI to Assess Thymic Function

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Cancer Center
    • New York
      • Commack, New York, United States
        • Memorial Sloan-Kettering Cancer Center at Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

MSK BMT clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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: MRI
Device: PET/CT scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

September 19, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-1244

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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