Trial Outcomes & Findings for Adult and Paediatric Patient Radiation Doses From Multidetector Row Computed Tomography Scans: a National Survey (NCT NCT01436006)

NCT ID: NCT01436006

Last Updated: 2015-09-18

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 6700 participants
• Primary outcome timeframe: One year
• Results posted on: 2015-09-18

Participant Flow

Participant milestones

Measure	CT Scan A total of 65 radiology departments, with 70 MDCT scanners, collected data of 5942 adult patients, randomly chosen, who underwent to CT examinations for common clinical for 5 common different protocols including also new examination that will be in the near future common practise as cardiac CT. A prevalence of multiphasic study was documented in many chest abdomen and pelvis (CAP) studies and abdominal studies.
Overall Study STARTED	6700
Overall Study COMPLETED	6663
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adult and Paediatric Patient Radiation Doses From Multidetector Row Computed Tomography Scans: a National Survey

Baseline characteristics by cohort

Measure	CT Scan n=6700 Participants patient with cancer
Age, Continuous	64 years STANDARD_DEVIATION 16 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6080 Participants n=5 Participants
Age, Categorical >=65 years	620 Participants n=5 Participants
Sex: Female, Male Female	2964 Participants n=5 Participants
Sex: Female, Male Male	3736 Participants n=5 Participants
Region of Enrollment Italy	6700 participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Outcome measures

Measure	Adult n=1109 Participants Adult patients submitted to head CT scan	Pediatric n=417 Participants Pediatric patients submitted to head CT scan
Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Head CT Examinations.	64 mGy Standard Deviation 17	28.7 mGy Standard Deviation 8.2

PRIMARY outcome

Timeframe: one year

Outcome measures

Measure	Adult n=1268 Participants Adult patients submitted to head CT scan	Pediatric n=326 Participants Pediatric patients submitted to head CT scan
Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest CT Examinations.	12 mGy Standard Deviation 6	4.3 mGy Standard Deviation 1.7

PRIMARY outcome

Timeframe: one year

Outcome measures

Measure	Adult n=1222 Participants Adult patients submitted to head CT scan	Pediatric n=250 Participants Pediatric patients submitted to head CT scan
Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Abdomen CT Examinations.	15 mGy Standard Deviation 9	8.9 mGy Standard Deviation 3.8

PRIMARY outcome

Timeframe: one year

Outcome measures

Measure	Adult n=287 Participants Adult patients submitted to head CT scan	Pediatric Pediatric patients submitted to head CT scan
Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Cardiac CT Examinations.	43 mGy Standard Deviation 24	—

PRIMARY outcome

Timeframe: one year

Outcome measures

Measure	Adult n=1237 Participants Adult patients submitted to head CT scan	Pediatric Pediatric patients submitted to head CT scan
Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest Abdomen and Pelvis CT Examinations.	14 mGy Standard Deviation 6	—

PRIMARY outcome

Timeframe: one year

Outcome measures

Measure	Adult n=584 Participants Adult patients submitted to head CT scan	Pediatric Pediatric patients submitted to head CT scan
Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Spine CT Examinations.	34 mGy Standard Deviation 20	—

Adverse Events

Adverse Reaction to CT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sergio Salerno

Università di Palermo

Phone: 00390916552315

Email: sergio.salerno@unipa.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place