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OpenTrials
Completed

NCT Number: NCT00606216

Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy

The purpose of this study is to learn about possible changes in brain anatomy and in thinking abilities, such as memory skills, in patients with cancer who receive treatment with chemotherapy alone or in combination with total body radiation before undergoing stem cell transplantation.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), acute undifferentiated or biphenotypic leukemia, myelodysplastic syndrome (MDS), Hodgkin's lymphoma, (HL) or non-Hodgkin's lymphoma (NHL), and in complete remission at the time of enrollment
  • Are scheduled to undergo conditioning treatment with (1) total body radiation (TBI) and chemotherapy or (2) chemotherapy alone prior to receiving a myeloablative allogeneic HSCT
  • Between 18 and 70 years of age.
  • Are English speaking.
  • Have capacity to give consent.

Healthy Control Inclusion Criteria:

  • Have no diagnosis of cancer except basal cell carcinoma
  • Between 18 and 70 years of age.
  • Are English speaking.
  • Have capacity to give consent

Exclusion criteria

  • Patients with signs and/or symptoms of central nervous system disease as determined by their physician or by a brain MRI, either at the time of enrollment or during the study period.
  • With disease progression at the time of enrollment or during the study period
  • With self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia
  • With a history of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness
  • With standard contraindications to MRI examinations

Healthy Control Exclusion Criteria:

  • Exposure to chemotherapy or radiation therapy for any medical condition
  • With self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia
  • With a history of neurological disorders, neurodegenerative disease, or traumatic brain injury with loss of consciousness
  • With standard contraindications to MRI examinations

Treatment and study plan

MRI and cognitive evaluation

Procedure

Patients will undergo a brain MRI study and a brief neuropsychological evaluation, at the time of enrollment for controls and prior to undergoing the conditioning treatment required for the stem cell transplant for patients. A follow-up MRI and cognitive evaluation will be performed approximately 12 months after the transplant for patients.

brain MRI study and a brief neuropsychological evaluation

Procedure

A brain MRI study and a brief neuropsychological evaluation will be performed at baseline (Time 1). A follow-up MRI and cognitive evaluation will be performed and about 12 months after the baseline for healthy controls

Primary outcomes

  1. assess changes in hippocampal volume & white matter integrity prospectively in adult ca pts who get treatment w/i chemotherapy alone or in combination with total body irradiation (TBI) before undergoing hematopoietic stem cell transplantation.

    Time frame: conclusion of the study

Secondary outcomes

  1. assess memory and executive functions prospectively in these patients. We will investigate whether there is an association between structural brain changes and cognitive performance.

    Time frame: conclusion of the study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Weill Medical College of Cornell University

Registry information

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2008
Registry last updated
Dec 10, 2015

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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