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Completed

NCT Number: NCT03342586

Using a Novel Functional MRI Technique to Evaluate for Neurotoxicity

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.

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Key information

Conditions

Central Nervous System Lymphoma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Immunocompetent patients with newly diagnosed or recurrent non-Hodgkins lymphoma involving the brain (primary or secondary), as demonstrated by MRI and histologic confirmation either by positive CSF cytology for lymphoma or a monoclonal lymphocyte population defined by cell surface markers, vitreous or uvea biopsy or brain biopsy
  • Age 18-80 years
  • Treatment plan for HDC-ASCT
  • Fluent in English
  • Patients who in the judgment of the investigators and/or consenting professional, are able to understand the purpose of the study and provide informed consent will be included.

Exclusion criteria

  • Claustrophobia
  • Any contraindication to the use of contrast and/or general guidelines for MR imaging as per standard Department of Radiology imaging guidelines
  • Unable to cooperate for MRI

Treatment and study plan

Resting State fMRI (rsfMRI)

Diagnostic Test

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).

Auditory Attention and Executive Functions Test

Other
  • 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.

memory test

Other

The Hopkins Verbal Learning Test-Revised (HVLT-R): The HVLT-R is a test of verbal learning and memory.

Motor Speed Test

Other

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.

Self Reported Quality of Life Questionnaire

Other

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.

Primary outcomes

  1. Change in resting state brain networks over time in participants with central nervous system lymphoma before and after treatment with high-dose chemotherapy with autologous stem cell transplantation through resting state fMRI results

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Rutgers University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2017
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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