Using a Novel Functional MRI Technique to Evaluate for Neurotoxicity

Central Nervous System Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03342586
• Other study ID #: 17-403
• Status: Completed
• Start date: November 7, 2017
• Est. completion date: August 4, 2022

Study information

• Verified date: August 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 4, 2022
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Lymphoma
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months

External Links

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