Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer

NCT02658513 | Completed

• 1 other identifier: 14OncN0013
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of the Thyroid; Cancer of Thyroid; Thyroid Cancer; Thyroid Carcinoma

Outcome Measures

Primary Outcomes (1)

• Quantify the bone marrow doses (in Gray) for each of the two blood sampling techniques.

  Within 1 month of completing recruitment

Secondary Outcomes (1)

• Quantify the radiation exposure (in milli-Sieverts) to staff for each of the two blood sampling techniques.

  Within 1 month of completing recruitment

Study Arms (1)

All Patients

All patients will undergo both of the following interventions: Lancet blood sampling Standard intravenous blood sampling

Other: Lancet blood sampling; Other: Standard intravenous blood sampling

Interventions

Lancet blood sampling OTHER

Blood samples will be obtained using a finger-prick (lancet) technique.

All Patients

Standard intravenous blood sampling OTHER

Blood samples will be obtained using a standard intravenous technique.

All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with thyroid cancer receiving radioiodine therapy after total thyroidectomy

You may qualify if:

• Patients undergoing inpatient radioiodine therapy for thyroid cancer

You may not qualify if:

• Pregnant or breastfeeding women
• Paediatric patients
• Patients with known trypanophobia

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead

Study Sites (1)

Royal Surrey County Hospital NHS Foundation Trust

Guildford, Surrey, GU2 7XX, United Kingdom

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• James W Scuffham, PhD

  Royal Surrey County Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: January 20, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)