NCT03342586

Using a Novel Functional MRI Technique to Evaluate for Neurotoxicity

Changes in Resting State Functional Connectivity in Patients With Central Nervous System Lymphoma Receiving High Dose Chemotherapy and Autologous Stem Cell Transplant

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test resting state functional Magnetic Resonance Imaging (rsfMRI) scans to see if rsfMRI scans are better than the standard task based fMRI scans at diagnosing or monitoring central nervous system lymphoma.

Conditions

• Central Nervous System Lymphoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Resting State fMRI (rsfMRI)	rsfMRI before receiving High-dose chemotherapy with autologous stem cell transplantation/HDC-ASCT (pre-HDC-ASCT), at approximately 3 months (+/- 2 weeks) after HDC-ASCT (early post-HDC-ASCT) and approximately 6months (+/- 2 weeks) after HDC-ASCT (late post-HDC-ASCT).
OTHER	Auditory Attention and Executive Functions Test	* Trail Making Test (Parts A \& B): Part A is a timed test of visual scanning and graphomotor speed; AT: 3 minutes. Part B is a timed measure of set-shifting; Administration Time (AT): 5 minutes. Test-retest reliabilities=0.64-0.94. * Brief Test of Attention-BTA assesses auditory working memory; AT: 10 minutes. Test-re-test reliability=0.70. * Controlled Oral Word Association Test-COWAT is a timed measure of phonemic verbal fluency. It requires the subject to generate as many words as possible, beginning with a given letter of the alphabet (i.e., F, A, and S). The subject is allowed 60 seconds per letter, and the resultant score is the total number of words produced. Test-retest reliability=0.88. AT: 5 minutes.
OTHER	Memory Test	The Hopkins Verbal Learning Test-Revised (HVLT-R): The HVLT-R is a test of verbal learning and memory.
OTHER	Motor Speed Test	Grooved Pegboard Test (GPT)-Dominant Hand and Non-Dominant Hand. It is a timed test of manual dexterity, in which the time to completion is scored separately for each hand.
OTHER	Self Reported Quality of Life Questionnaire	The Functional Assessment of Cancer Therapy-Brain Cancer (FACT-BR Version 4) consists of 46 questions with five domains assessing physical well-being, social/family well-being, emotional well-being, functional well being, additional concerns. The neuropsychological and QOL assessments will be performed by a neuropsychologist or by a trained RSA under the neuropsychologist's direct supervision.

Timeline

• Start date: 2017-11-07
• Primary completion: 2022-08-04
• Completion: 2022-08-04
• First posted: 2017-11-17
• Last updated: 2022-08-08

Locations

1 site across 1 country: United States