Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer
|ClinicalTrials.gov Identifier: NCT02658513|
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : March 11, 2020
Recently published European guidance recommends the evaluation of the radiation dose to the bone marrow in patients undergoing radioiodine therapy for thyroid cancer. The methods described in these guidelines require serial blood samples to be taken from the patient, followed by a sophisticated analysis to determine the radiation dose. However, radiation risk assessments carried out locally have indicated that a relatively high radiation exposure will be received by the operator taking the blood samples, which may prohibit this procedure being carried out routinely.
The radiation dose to the operator will be lowered if the duration of the blood sampling procedure were reduced. The investigators hypothesize that the use of a lancet and pipette to collect blood from the finger tip will greatly reduce the time spent in proximity to the patient, significantly reducing the operator exposure and allowing this procedure to be performed routinely. The proposed method is also less invasive for the patient compared to the intravenous sampling recommended in the guidelines. A proof-of-principal pilot project using radioiodine diluted to the expected concentration in blood has indicated that using very small volumes of blood (such as from a lancet) does not compromise the accuracy of the dosimetry measurement when compared to large-volume standard blood samples.
The primary aim of this study is to investigate whether sampling a small volume of blood using a lancet and pipette can replace standard intravenous blood samples for bone marrow dosimetry in patients undergoing radioiodine treatment for thyroid cancer. Statistical tests will determine whether there is a significant difference between the doses calculated using each blood sampling method. In addition, the investigators will measure the radiation exposure received by the operator during each procedure using Electronic Portable Dosimeters. The results of these measurements will be used to quantify the reduction in operator radiation exposure afforded by the new technique.
|Condition or disease||Intervention/treatment|
|Cancer of the Thyroid Cancer of Thyroid Thyroid Cancer Thyroid Carcinoma||Other: Lancet blood sampling Other: Standard intravenous blood sampling|
|Study Type :||Observational|
|Actual Enrollment :||35 participants|
|Official Title:||Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 2019|
All patients will undergo both of the following interventions:
Lancet blood sampling Standard intravenous blood sampling
Other: Lancet blood sampling
Blood samples will be obtained using a finger-prick (lancet) technique.
Other: Standard intravenous blood sampling
Blood samples will be obtained using a standard intravenous technique.
- Quantify the bone marrow doses (in Gray) for each of the two blood sampling techniques. [ Time Frame: Within 1 month of completing recruitment ]
- Quantify the radiation exposure (in milli-Sieverts) to staff for each of the two blood sampling techniques. [ Time Frame: Within 1 month of completing recruitment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658513
|Royal Surrey County Hospital NHS Foundation Trust|
|Guildford, Surrey, United Kingdom, GU2 7XX|
|Principal Investigator:||James W Scuffham, PhD||Royal Surrey County Hospital NHS Foundation Trust|