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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00606216
Enrollment
66
Registered
2008-02-01
Start date
2007-01-31
Completion date
2015-12-31
Last updated
2015-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Undifferentiated Leukemia, Biphenotypic Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma

Keywords

MRI

Brief summary

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.

Interventions

PROCEDUREMRI and cognitive evaluation

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.

PROCEDUREbrain MRI study and a brief neuropsychological evaluation

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

Sponsors

Weill Medical College of Cornell University
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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.conclusion of the study

Secondary

MeasureTime frame
assess memory and executive functions prospectively in these patients. We will investigate whether there is an association between structural brain changes and cognitive performance.conclusion of the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026