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Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)

Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00581958
Enrollment
198
Registered
2007-12-28
Start date
2007-11-30
Completion date
2018-10-31
Last updated
2018-11-05

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

Conditions

Cancer

Keywords

total body irradiation, Cancer, Hematopoietic System

Brief summary

The purpose of this study is to develop blood tests and urine tests that can tell doctors how much radiation a person has been exposed to. Doctors know how much radiation patients are exposed to in certain medical situations. An example of this would be radiation treatment for cancer. Radiation treatment machines are programmed to give exact doses of radiation.

Detailed description

MSKCC patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have blood drawn and urine collected for use in the validation and refinement of new methods for rapid high-throughput radiation biodosimetry. These blood and urine samples will be collected before, and at defined times after TBI. Blood sampling will occur in the same manner that it does during routine patient care during HSCT.

Interventions

OTHERBlood Samples

blood (approximately two 4 ml; equivalent to less than 2 tablespoon) and urine (a cup of urine) samples or testing a total of three times. Blood will be drawn and urine will be collected once before radiation treatment and twice after first radiation treatment.

Sponsors

Georgetown University
CollaboratorOTHER
National Institute of Standards and Technology
CollaboratorUNKNOWN
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patients greater than 4 years of age at Memorial Sloan-Kettering Cancer Center * Must be undergoing hematopoietic stem cell transplantation (either autologous or allogenic) in conjunction with a conditioning regimen that includes TBI (single or multiple fraction) * Functional central venous catheter

Exclusion criteria

* No subjects will be excluded from the proposed research study for demographic reasons. Treatment with growth factors, such as keratinocyte growth factor (KGF), will not be grounds for exclusion. * Subjects who will receive radiation therapy within 5 days prior to TBI will be excluded. * Subjects who will receive systemic antineoplastic chemotherapy within 7 days prior to TBI not have research bloods collected. Only urine will be collected from these patients. * Based on current knowledge, we will not a priori exclude patients based on disease status (ie, patients in or out of remission will be included in this study), type of disease(ie, chromosomal breakage syndromes), or previous therapies (unless

Design outcomes

Primary

MeasureTime frameDescription
To develop, validate and refine high-throughput platforms for radiation biodosimetry using metabolomic assays.3 yearsThe approach involves profiling blood and urinary metabolites that are specific for radiation exposure and dose.

Countries

United States

Outcome results

None listed

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