Trial Outcomes & Findings for Impact of C-arm CT in Patients With HCC Undergoing TACE: Optimal Imaging Guidance (NCT NCT00926536)

Results Overview

Dose area product (DAP) is a measure of the entire amount of energy (radiation dose) delivered to the patient by the beam (indicator of stochastic dose)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

Duration of a TACE procedure, an average of 2 hours

Results posted on

2016-04-04

Participant Flow

Study was open from 01/13/2009 thru 10/13/2010. During this period, subjects with HCC who were scheduled to undergo TACE were approached for permission to participate in the study.

Participant milestones

Participant milestones
Measure	C-arm CT +DSA as Needed C-arm CT in imaging guidance of TACE supplemented with DSA as needed for vessel tracking and navigation	DSA Only Only Digital subtraction images used for vessel tracking and tumor navigation
Overall Study STARTED	44	43
Overall Study COMPLETED	43	41
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	C-arm CT +DSA as Needed C-arm CT in imaging guidance of TACE supplemented with DSA as needed for vessel tracking and navigation	DSA Only Only Digital subtraction images used for vessel tracking and tumor navigation
Overall Study Physician Decision	1	2

Baseline Characteristics

Impact of C-arm CT in Patients With HCC Undergoing TACE: Optimal Imaging Guidance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C-arm CT + DSA as Needed n=43 Participants C-arm CT in imaging guidance of TACE supplemented by DSA as needed for vessel navigation and tracking	DSA Only n=41 Participants DSA images only used for vessel navigation and tracking	Total n=84 Participants Total of all reporting groups
Age, Customized <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Customized Over 18 years old	43 participants n=5 Participants	41 participants n=7 Participants	84 participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	29 Participants n=7 Participants	66 Participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of a TACE procedure, an average of 2 hours

Population: DAP measured in both groups

Dose area product (DAP) is a measure of the entire amount of energy (radiation dose) delivered to the patient by the beam (indicator of stochastic dose)

Outcome measures

Outcome measures
Measure	C-arm CT +DSA as Needed n=43 Participants C-arm CT images used for navigational purposes supplemented by DSA if needed	DSA Only n=41 Participants Only DSA imaging used for navigational purposes
Dose Area Product (DAP)	184.2 Gy.cm2 Interval 148.2 to 220.2	137.4 Gy.cm2 Interval 101.1 to 173.7

PRIMARY outcome

Timeframe: Duration of a TACE procedure, an average of 2 hours

Population: CD measured in both groups

CD - a measurement of total radiation to the skin (measure of a deterministic dose)

Outcome measures

Outcome measures
Measure	C-arm CT +DSA as Needed n=43 Participants C-arm CT images used for navigational purposes supplemented by DSA if needed	DSA Only n=41 Participants Only DSA imaging used for navigational purposes
Cumulative Dose (CD), a Measure of Radiation Dose	626.4 mGy Interval 439.5 to 813.3	784.7 mGy Interval 537.3 to 1032.1

Adverse Events

C-arm CT + DSA as Needed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DSA Only

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	C-arm CT + DSA as Needed n=43 participants at risk C-arm CT used for the purposes of navigation, supplemented by DSA if needed	DSA Only n=41 participants at risk DSA only used for navigation
Surgical and medical procedures Arterial Hematoma	0.00% 0/43 • The duration of the procedure, since this was an imaging study. TACE procedures are an average of 2 hours.	2.4% 1/41 • Number of events 1 • The duration of the procedure, since this was an imaging study. TACE procedures are an average of 2 hours.

Other adverse events

Adverse event data not reported

Additional Information

Dr Nishita Kothary

Stanford University

Phone: 6504986020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60