Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Quantify the bone marrow doses (in Gray) for each of the two blood sampling techniques.
研究概览
简要总结
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.
详细描述
Recruitment:
Patients will be recruited to the trial from the pool of routine referrals for this therapy. Potential participants will receive an information leaflet via the post several weeks in advance of attendance at clinic. Patients will have the opportunity to telephone the study team during this time to answer any questions. Patients who are interested in participating will have the procedure further explained verbally by a physicist on the study team upon attending for therapy. The patient will then have time to consider whether or not to participate in the study. Written consent will be sought before commencing the therapy.
Procedures:
In light of the recent guidelines, the proposed new clinical protocol will include blood samples taken from the patient during the in-patient stay. On the day of treatment, blood samples will be taken at 2h and 6h after radioiodine administration, at the same time as the clearance measurements. Thereafter, a blood sample will be taken from the patient once per day, at the same time as one of the clearance measurements. In addition, a further blood sample will be taken when the patient attends for whole-body and SPECT/CT scans. These blood samples will then be analysed in the laboratory using standard radiation measurement procedures to determine the blood dose according to the European guidelines.
This study will involve the patient having blood samples taken by two different methods at each of the time points described above. In the first method, a butterfly needle will be used to gain intravenous access at the antecubital fossa, and a heparinised vacutainer will be used to collect a 4ml blood sample. The needle will then be removed and the venepuncture site dressed with a plaster. In the second method, a single-use safety lancet will be used to puncture the skin on the finger, and a small pipette used to collect a small quantity of blood. The entire pipette will be transferred to a sample tube for later processing. The puncture site on the finger will then be dressed with a small plaster. The exact start and end times for each sample will be recorded using a radio-controlled standard clock.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing inpatient radioiodine therapy for thyroid cancer
排除标准
- •Pregnant or breastfeeding women
- •Paediatric patients
- •Patients with known trypanophobia
结局指标
主要结局
Quantify the bone marrow doses (in Gray) for each of the two blood sampling techniques.
时间窗: Within 1 month of completing recruitment
次要结局
- Quantify the radiation exposure (in milli-Sieverts) to staff for each of the two blood sampling techniques.(Within 1 month of completing recruitment)
研究者
James Scuffham
Clinical Scientist
Royal Surrey County Hospital NHS Foundation Trust