Occupational Exposure to Radiation
Conditions
Keywords
Occupational Exposure to Radiation
Brief summary
The PREFER II trial primary objective of the trial is to show how much radiation attenuation is provided by XPF thyroid collars in absolute and relative terms.
Detailed description
The PREFER II trial has three main objectives. The primary objective of the trial is to show how much radiation attenuation is provided by XPF thyroid collars in absolute and relative terms. The secondary objective of the study is to measure and compare the amount of radiation that interventional radiologists are exposed to per case in an interventional suite setting using FDA approved XPF thyroid collars or standard 0.5 mm Pb equivalent thyroid collars. The third objective is to assess the operator comfort wearing the XPF protection devices. In order to achieve these objectives, measurements will be performed in 150 consecutive interventional procedures requiring C-arm fluoroscopy performed at BCVI. A prospective randomization will be performed, assigning participants to wear their own standard 0.5 mm Pb equivalent thyroid collar or to wear the FDA approved XPF thyroid collar. Radiation exposure will be monitored with 2 radiation detectors (TLDs, one inside and one outside the thyroid collar) which the participant is required to wear. After each procedure the participant will be asked to rate the comfort of wearing the devices on a scale from 1 to 100.
Interventions
DEVICEXPF thyroid collar
Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions.
DEVICEStandard 0.5mm lead equivalent thyroid collar
Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during the same type of comparator fluoroscopy guided interventions. Comparator arm uses same type of lead thyroid collar but the XPF under investigation.
Sponsors
Baptist Health South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Interventional Radiologists practicing in Baptist Cardiac & Vascular Institute * consecutive endovascular procedure requiring C-arm fluoroscopy
Exclusion criteria
* Interventional Neuroradiologists and Interventional Cardiologists will not be included in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change | 1 day | Radiation attenuation. The null hypothesis is that the XPF thyroid collar is equal to the standard 0.5mm Pb lead equivalent thyroid collar with regard to radiation attenuation/transmission in relative (%) terms. The alternative hypothesis is that the XPF thyroid collar is superior or inferior to the standard thyroid collar. Based on our results obtained during the 60 procedures (PREFER trial), 150 procedures are required to demonstrate a significant difference with an alpha level of 5% and a power of 80%. Radiation attenuation percentage is measure by interrogation of the lead attenuates X-rays counter required to be used in all interventional radiology clinical procedures by each physician operator. The interrogation is done by measuring the energy imparted per unit mass in the counter wore by ionizing radiation to matter at the specified point. The International System of Units (SI) unit of absorbed dose is the joule per kilogram. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wearing Comfort of the Collar on a Scale From 0-100. | 1 day | Operators are asked directly after each procedure to rate the wearing comfort, graded worst to best. 0 means low comfort (worse outcome) and 100 is the best comfort level (best outcome) with wearing the collar. |
| Radiation Exposure (uSv) for for Both the Thyroid and Equivalent Collars | 1 day | (day 1) Operators are asked directly after each procedure to rate the wearing comfort Radiation exposure will be monitored with radiation detectors (TLDs, 2 attached to the collar) which the participant is required to wear. Exposure is measured as the energy imparted per unit mass by ionizing radiation to the matter at the specified time of the procedure. The International System of Units (SI) unit of absorbed dose is the joule per kilogram. The special name for this unit is the gray (Gy). For purposes of radiation protection and assessing dose or risk to humans in general terms, the quantity normally calculated is the mean absorbed dose in an organ or tissue. |
| Radiation Exposure (uSv) for XPF Caps and the Equivalent Caps | 1 day | (day 1) Operators are asked directly after each procedure to rate the wearing comfort Radiation exposure will be monitored with radiation detectors, which the participant is required to wear. Exposure is measured as the energy imparted per unit mass by ionizing radiation to the matter at the specified time of the procedure. The International System of Units (SI) unit of absorbed dose is the joule per kilogram. The special name for this unit is the gray (Gy). For purposes of radiation protection and assessing dose or risk to humans in general terms, the quantity normally calculated is the mean absorbed dose in an organ or tissue. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XPF Thyroid Collar Administration of the XPF Thyroid Collar.
XPF thyroid collar: Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions. | 58 |
| Equivalent Collar Administration of the Standard 0.5mm lead-equivalent thyroid collar.
Standard 0.5mm lead equivalent thyroid collar: Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions. | 48 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 18 | 10 |
Baseline characteristics
| Characteristic | Equivalent Collar | XPF Thyroid Collar | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 22 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 36 Participants | 62 Participants |
| Age, Continuous | 50 Year STANDARD_DEVIATION 25 | 50 Year STANDARD_DEVIATION 25 | 50 Year STANDARD_DEVIATION 25 |
| Region of Enrollment United States | 48 participants | 58 participants | 106 participants |
| Sex: Female, Male Female | 24 Participants | 26 Participants | 50 Participants |
| Sex: Female, Male Male | 24 Participants | 32 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 48 |
| other Total, other adverse events | 0 / 58 | 0 / 48 |
| serious Total, serious adverse events | 0 / 58 | 0 / 48 |
Outcome results
Primary
Percentage Change
Radiation attenuation. The null hypothesis is that the XPF thyroid collar is equal to the standard 0.5mm Pb lead equivalent thyroid collar with regard to radiation attenuation/transmission in relative (%) terms. The alternative hypothesis is that the XPF thyroid collar is superior or inferior to the standard thyroid collar. Based on our results obtained during the 60 procedures (PREFER trial), 150 procedures are required to demonstrate a significant difference with an alpha level of 5% and a power of 80%. Radiation attenuation percentage is measure by interrogation of the lead attenuates X-rays counter required to be used in all interventional radiology clinical procedures by each physician operator. The interrogation is done by measuring the energy imparted per unit mass in the counter wore by ionizing radiation to matter at the specified point. The International System of Units (SI) unit of absorbed dose is the joule per kilogram.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XPF Thyroid Collar | Percentage Change | 79.7 percentage change | Standard Deviation 25.8 |
| Equivalent Collar | Percentage Change | 71.9 percentage change | Standard Deviation 34.2 |
Secondary
Radiation Exposure (uSv) for for Both the Thyroid and Equivalent Collars
(day 1) Operators are asked directly after each procedure to rate the wearing comfort Radiation exposure will be monitored with radiation detectors (TLDs, 2 attached to the collar) which the participant is required to wear. Exposure is measured as the energy imparted per unit mass by ionizing radiation to the matter at the specified time of the procedure. The International System of Units (SI) unit of absorbed dose is the joule per kilogram. The special name for this unit is the gray (Gy). For purposes of radiation protection and assessing dose or risk to humans in general terms, the quantity normally calculated is the mean absorbed dose in an organ or tissue.
Time frame: 1 day
Population: XPF thyroid collar and the equivalent collar are combined under one outcome measure as the outcome measure is comparing the arms and not as individual measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XPF Thyroid Collar | Radiation Exposure (uSv) for for Both the Thyroid and Equivalent Collars | 272.3 Gy | Standard Deviation 373.3 |
| Equivalent Collar | Radiation Exposure (uSv) for for Both the Thyroid and Equivalent Collars | 98.2 Gy | Standard Deviation 203.1 |
Secondary
Radiation Exposure (uSv) for XPF Caps and the Equivalent Caps
(day 1) Operators are asked directly after each procedure to rate the wearing comfort Radiation exposure will be monitored with radiation detectors, which the participant is required to wear. Exposure is measured as the energy imparted per unit mass by ionizing radiation to the matter at the specified time of the procedure. The International System of Units (SI) unit of absorbed dose is the joule per kilogram. The special name for this unit is the gray (Gy). For purposes of radiation protection and assessing dose or risk to humans in general terms, the quantity normally calculated is the mean absorbed dose in an organ or tissue.
Time frame: 1 day
Population: XPF caps and the equivalent caps are combined under one outcome measure as the outcome measure is comparing the arms and not as individual measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XPF Thyroid Collar | Radiation Exposure (uSv) for XPF Caps and the Equivalent Caps | 224.1 Gy | Standard Deviation 266.1 |
| Equivalent Collar | Radiation Exposure (uSv) for XPF Caps and the Equivalent Caps | 48.1 Gy | Standard Deviation 124.7 |
Secondary
Wearing Comfort of the Collar on a Scale From 0-100.
Operators are asked directly after each procedure to rate the wearing comfort, graded worst to best. 0 means low comfort (worse outcome) and 100 is the best comfort level (best outcome) with wearing the collar.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XPF Thyroid Collar | Wearing Comfort of the Collar on a Scale From 0-100. | 85.0 score on a scale | Standard Deviation 8.8 |
| Equivalent Collar | Wearing Comfort of the Collar on a Scale From 0-100. | 83.3 score on a scale | Standard Deviation 13.1 |