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Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT02658513
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
James Scuffham, Royal Surrey County Hospital NHS Foundation Trust

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.


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

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
All Patients

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.




Primary Outcome Measures :
  1. Quantify the bone marrow doses (in Gray) for each of the two blood sampling techniques. [ Time Frame: Within 1 month of completing recruitment ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with thyroid cancer receiving radioiodine therapy after total thyroidectomy
Criteria

Inclusion Criteria:

  • Patients undergoing inpatient radioiodine therapy for thyroid cancer

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658513


Locations
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United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, United Kingdom, GU2 7XX
Sponsors and Collaborators
Royal Surrey County Hospital NHS Foundation Trust
Investigators
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Principal Investigator: James W Scuffham, PhD Royal Surrey County Hospital NHS Foundation Trust
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Responsible Party: James Scuffham, Clinical Scientist, Royal Surrey County Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02658513    
Other Study ID Numbers: 14OncN0013
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms