RecruitingNCT06144151

A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity


Sponsor

M.D. Anderson Cancer Center

Enrollment

100 participants

Start Date

Feb 8, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

To learn about the relationship between changes in pupil size and reactivity and the start of neurological side effects in patients after receiving CAR-T cell therapy.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Ages Eligible for Study: 18 Years and above (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Patient with histologically proven DLBCL, PMBCL or tFL, or follicular Lymphoma receiving axi-cel CAR-T cell therapy in the inpatient setting at MD Anderson Cancer Center
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria3

  • Patients who have already been administered CAR-T cell therapy.
  • The patient who is unwilling or unable to comply with the requirements of the study including being able to be assessed with pupillometer
  • Patient has a condition which places him at an unacceptable risk as determined by the investigator

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Interventions

DEVICENeurOptics® NPi®-300 Pupillometer

The pupilometer is a non-invasive device which will be placed in front of your eyes, one at a time. It looks like a handheld spotlight or scanner, with a small plastic guide sticking out that will be placed against your cheek to help keep the device in place during the scan. It will not touch your eye. Both your left and right eyes will be measured with the device each time. Scanning with the pupilometer will take less than 5 minutes total for both eyes.


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06144151


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