Using a Novel Functional MRI Technique to Evaluate for Neurotoxicity

NCT03342586 | Completed

• 1 other identifier: 17-403
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

resting state functional Magnetic Resonance Imaging; rsfMRI; 17-403

Outcome Measures

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

  6 months

Study Arms (1)

Central Nervous System Lymphoma

Participants will have non-Hodgkins lymphoma involving the brain (primary or secondary)

Diagnostic Test: Resting State fMRI (rsfMRI); Other: Auditory Attention and Executive Functions Test; Other: Memory Test; Other: Motor Speed Test; Other: Self Reported Quality of Life Questionnaire

Interventions

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).

Central Nervous System Lymphoma

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.

Central Nervous System Lymphoma

Memory Test OTHER

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

Central Nervous System Lymphoma

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.

Central Nervous System Lymphoma

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.

Central Nervous System Lymphoma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects will be identified by a member of the patient's treatment team, listed protocol investigators, or Neuroradiology research team at Memorial Sloan Kettering Cancer Center (MSKCC).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Rutgers University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Related Info

Study Officials

• Behroze Vachha, MD, PhD

  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: November 9, 2017
• First Posted: November 17, 2017
• Study Start: November 7, 2017
• Primary Completion: August 4, 2022
• Study Completion: August 4, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

US (1)