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

NCT02909075 | Completed

• 1 other identifier: 16-1244
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 4

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.

Conditions

CD34 Selected Peripheral Blood Stem Cell Graft

Keywords

PET/CT; MRI; Assess Thymic Function; 16-1244

Outcome Measures

Primary Outcomes (1)

• change in thymic size

  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

Study Arms (1)

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

Interventions

PET/CT scans DEVICE

PET/CT scans and MRI

MRI DEVICE

PET/CT scans and MRI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MSK BMT clinic

You may qualify if:

• Patient's age is ≥18 or ≤65 years old.
• Patients must have a plan to receive a CD34-selected peripheral blood stem cell graft.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (4)

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan-Kettering Cancer Center at Commack

Commack, New York, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Heiko Schoder, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 21, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (4)