Simplification of Low Level Internal Dosimetry

Simplification of Low Level Internal Dosimetry

Sponsors

Lead Sponsor: Royal Marsden NHS Foundation Trust

Source Royal Marsden NHS Foundation Trust
Brief Summary

This is a pilot study with the primary aim being to identify the minimum number of scans and measurements necessary to determine accurately the absorbed radiation doses delivered from internal sources of radiation administered for diagnostic nuclear medicine procedures.

Detailed Description

A study to develop practical methods of accurate low radiation absorbed dose measurement in patients referred for nuclear medicine scans. There is currently very little information on and therefore understanding of the effects of exposure to low levels of radiation on patients or radiation workers. Assumptions are largely based on evidence from high radiation doses following nuclear incidents which may not be applicable to medical procedures. Underestimation of the radiation effects incurs greater risk to patients than is currently assumed, while overestimation can prevent more informative scans that would be obtained from higher administered activities. This research study answers an invitation from the Department of Health Policy research programme to improve our understanding of those low radiation dose risks. Over 600,000 patients have nuclear medicine scans in the UK each year, presenting an opportunity to accurately measure low radiation doses and follow up the effects on a large number of patients. This study will develop practical methods to measure accurately the radiation doses delivered to patients referred for nuclear medicine positron emission tomography (PET) and single photon emission computed tomography (SPECT) scans. Five patients referred for each of 7 diagnostic nuclear medicine procedures will undergo up to 7 quantitative PET/SPECT scans and up to 10 whole body radiation retention measurements over the course of 1-2 days to enable the absorbed radiation doses to be calculated accurately. Analysis of subsets of these measurements will be performed to identify the timing and minimum number of measurements necessary for accurate dose estimates. The longer term aim is that these methods and results will subsequently be used to inform a national epidemiological (epidemiology is the study of factors affecting the health and illness of populations) study on the effects of low doses of radiation.

Overall Status Unknown status
Start Date 2018-07-18
Completion Date 2020-08-30
Primary Completion Date 2020-02-28
Study Type Observational
Primary Outcome
Measure Time Frame
The uncertainty on the absorbed dose calculation 6-24 hours
Secondary Outcome
Measure Time Frame
The range of absorbed doses delivered 6-24 hours
Enrollment 35
Condition
Intervention

Intervention Type: Other

Intervention Name: 18-F FDG PET/CT dosimetry scans and measurements

Description: Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

Arm Group Label: 18-F FDG PET/CT

Intervention Type: Other

Intervention Name: Ga-68 PSMA PET/CT dosimetry scans and measurements

Description: Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

Arm Group Label: Ga-68 PSMA PET/CT

Intervention Type: Other

Intervention Name: 68-Ga Dotatate PET/CT dosimetry scans and measurements

Description: Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

Arm Group Label: 68-Ga Dotatate PET/CT

Intervention Type: Other

Intervention Name: 99mTc Pertechnetate Thyroid dosimetry scans and measurements

Description: Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

Arm Group Label: 99mTc Pertechnetate Thyroid Scan

Intervention Type: Other

Intervention Name: 99mTc DMSA(III) Renal dosimetry scans and measurements

Description: Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

Arm Group Label: 99mTc DMSA(III) Renal Scan

Intervention Type: Other

Intervention Name: 99mTc MAG3 Renal dosimetry scans and measurements

Description: Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

Arm Group Label: 99mTc MAG3 Renal Scan

Intervention Type: Other

Intervention Name: 99mTc MDP Bone dosimetry scans and measurements

Description: Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

Arm Group Label: 99mTc MDP Bone Scan

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: * All patients able to undergo the procedures necessary to acquire sufficient data for dosimetry, consisting of up 7 nuclear medicine scans and 10 external radiation retention measurements over a time period of up to 24 hours Exclusion Criteria: - Patients unable or unwilling to undergo further procedures that may include scans and external retention measurements. - Paediatric patients 18 years of age and under. - Pregnant patients.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Glenn Flux Principal Investigator Royal Marsden NHS Foundation Trust
Overall Contact

Last Name: Yvonne Fox-Miller

Phone: +44 208 661 3760

Email: [email protected]

Location
Facility: Status: The Royal Marsden NHS Foundation Trust
Location Countries

United Kingdom

Verification Date

2018-07-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Arm Group

Label: 18-F FDG PET/CT

Description: Patients receiving routine diagnostic scan

Label: Ga-68 PSMA PET/CT

Description: Patients receiving routine diagnostic scan

Label: 68-Ga Dotatate PET/CT

Description: Patients receiving routine diagnostic scan

Label: 99mTc Pertechnetate Thyroid Scan

Description: Patients receiving routine diagnostic scan

Label: 99mTc DMSA(III) Renal Scan

Description: Patients receiving routine diagnostic scan

Label: 99mTc MAG3 Renal Scan

Description: Patients receiving routine diagnostic scan

Label: 99mTc MDP Bone Scan

Description: Patients receiving routine diagnostic scan

Acronym SOLLID
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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