Simplification of Low Level Internal Dosimetry

NCT ID: NCT03580161

Last Updated: 2023-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-30

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Exposure to Medical Diagnostic Radiation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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18-F FDG PET/CT

Patients receiving routine diagnostic scan

18-F FDG PET/CT dosimetry scans and measurements

Intervention Type OTHER

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

Ga-68 PSMA PET/CT

Patients receiving routine diagnostic scan

Ga-68 PSMA PET/CT dosimetry scans and measurements

Intervention Type OTHER

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

68-Ga Dotatate PET/CT

Patients receiving routine diagnostic scan

68-Ga Dotatate PET/CT dosimetry scans and measurements

Intervention Type OTHER

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

99mTc Pertechnetate Thyroid Scan

Patients receiving routine diagnostic scan

99mTc Pertechnetate Thyroid dosimetry scans and measurements

Intervention Type OTHER

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

99mTc DMSA(III) Renal Scan

Patients receiving routine diagnostic scan

99mTc DMSA(III) Renal dosimetry scans and measurements

Intervention Type OTHER

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

99mTc MAG3 Renal Scan

Patients receiving routine diagnostic scan

99mTc MAG3 Renal dosimetry scans and measurements

Intervention Type OTHER

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

99mTc MDP/HDP Bone Scan

Patients receiving routine diagnostic scan

99mTc MDP/HDP Bone dosimetry scans and measurements

Intervention Type OTHER

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

Interventions

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18-F FDG PET/CT dosimetry scans and measurements

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

Intervention Type OTHER

Ga-68 PSMA PET/CT dosimetry scans and measurements

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

Intervention Type OTHER

68-Ga Dotatate PET/CT dosimetry scans and measurements

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

Intervention Type OTHER

99mTc Pertechnetate Thyroid dosimetry scans and measurements

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

Intervention Type OTHER

99mTc DMSA(III) Renal dosimetry scans and measurements

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

Intervention Type OTHER

99mTc MAG3 Renal dosimetry scans and measurements

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

Intervention Type OTHER

99mTc MDP/HDP Bone dosimetry scans and measurements

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glenn Flux

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

References

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Flux G, Murray I, Rushforth D, Gape P, Abreu C, Lee M, Ribeiro A, Gregory R, Chittenden S, Thurston J, Du Y, Gear J. SOLLID - a single centre study to develop methods to investigate the effects of low radiation doses within nuclear medicine, to enable multicentre epidemiological investigations. Br J Radiol. 2021 Mar 1;94(1119):20200072. doi: 10.1259/bjr.20200072. Epub 2020 Sep 9.

Reference Type DERIVED
PMID: 32903035 (View on PubMed)

Other Identifiers

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CCR 4767

Identifier Type: -

Identifier Source: org_study_id

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