Trial Outcomes & Findings for Clinical Trial to Evaluate the Accuracy of [99mTc] ThromboView in the Detection of Deep Vein Thrombosis (NCT NCT00123734)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

94 participants

Primary outcome timeframe

May 2007

Results posted on

2009-08-24

Participant Flow

94 participants were enrolled into the study. The first participant was enrolled on 4 March 2005, and the last participant was enrolled on 6 February 2006. All participants were enrolled in hosptial.

12 participants did not recieve study drug (6 had no venography, 3 withdrew consent, 2 had an alternate diagnosis and 1 was a dropout).

Participant milestones

Participant milestones
Measure	Group 1
Overall Study STARTED	82
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1
Overall Study Death	3
Overall Study Lost to Follow-up	3
Overall Study Dropout	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Clinical Trial to Evaluate the Accuracy of [99mTc] ThromboView in the Detection of Deep Vein Thrombosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=82 Participants
Age Continuous	55.12 years STANDARD_DEVIATION 15.148 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: May 2007

Population: Number of participants with suspected initial DVT with evaluable images

Outcome measures

Outcome measures
Measure	1 Hour Image Set n=26 Participants Review of whole leg 1 hour images	3 Hour Image Set n=26 Participants Review of 3 hour whole leg images	15 Min and 1 Hour Image Set n=26 Participants Review of whole leg 15 minute and 1 hour images in combination	15 Minute and 3 Hour Image Set n=26 Participants Review of whole leg 15 minute and 3 hour images in combination
To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Excluded Initial DVT	76.9 % Specificity Interval 58.0 to 89.0	65.4 % Specificity Interval 46.2 to 80.6	100 % Specificity Interval 87.1 to 100.0	96.2 % Specificity Interval 81.1 to 99.3

PRIMARY outcome

Timeframe: September 2005

Outcome measures

Outcome measures
Measure	1 Hour Image Set n=27 Participants Review of whole leg 1 hour images	3 Hour Image Set n=27 Participants Review of 3 hour whole leg images	15 Min and 1 Hour Image Set n=27 Participants Review of whole leg 15 minute and 1 hour images in combination	15 Minute and 3 Hour Image Set n=27 Participants Review of whole leg 15 minute and 3 hour images in combination
To Provide Estimates of the Sensitivity of [99mTc] ThromboView® in Patients With Confirmed Initial DVT.	37.0 % Sensitivity Interval 21.5 to 55.8	74.1 % Sensitivity Interval 55.3 to 86.8	11.1 % Sensitivity Interval 3.9 to 28.1	59.3 % Sensitivity Interval 40.7 to 75.5

SECONDARY outcome

Timeframe: May 2007

Population: Number of participants with suspected recurrent DVT with evaluable images

Outcome measures

Outcome measures
Measure	1 Hour Image Set n=11 Participants Review of whole leg 1 hour images	3 Hour Image Set n=11 Participants Review of 3 hour whole leg images	15 Min and 1 Hour Image Set n=11 Participants Review of whole leg 15 minute and 1 hour images in combination	15 Minute and 3 Hour Image Set n=11 Participants Review of whole leg 15 minute and 3 hour images in combination
To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Suspected Recurrent DVT in Whom Disease Recurrence Has Been Excluded	36.4 % Specificity Interval 15.2 to 64.6	72.7 % Specificity Interval 43.4 to 90.3	63.6 % Specificity Interval 35.4 to 84.8	72.7 % Specificity Interval 43.4 to 90.3

SECONDARY outcome

Timeframe: May 2007

Population: Number of participants with suspected initial DVT with evaluable images

Outcome measures

Outcome measures
Measure	1 Hour Image Set n=29 Participants Review of whole leg 1 hour images	3 Hour Image Set n=30 Participants Review of 3 hour whole leg images	15 Min and 1 Hour Image Set n=29 Participants Review of whole leg 15 minute and 1 hour images in combination	15 Minute and 3 Hour Image Set n=30 Participants Review of whole leg 15 minute and 3 hour images in combination
To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT	86.2 % Specificity Interval 69.4 to 94.5	70.0 % Specificity Interval 52.1 to 83.3	100 % Specificity Interval 88.3 to 100.0	96.7 % Specificity Interval 83.3 to 99.4

SECONDARY outcome

Timeframe: May 2007

Population: Number of participants with suspected initial DVT with evaluable images

Outcome measures

Outcome measures
Measure	1 Hour Image Set n=19 Participants Review of whole leg 1 hour images	3 Hour Image Set n=20 Participants Review of 3 hour whole leg images	15 Min and 1 Hour Image Set n=19 Participants Review of whole leg 15 minute and 1 hour images in combination	15 Minute and 3 Hour Image Set n=19 Participants Review of whole leg 15 minute and 3 hour images in combination
To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT	42.1 % Sensitivity Interval 23.1 to 63.7	90.0 % Sensitivity Interval 69.9 to 97.2	15.8 % Sensitivity Interval 5.5 to 37.6	84.2 % Sensitivity Interval 62.4 to 94.5

SECONDARY outcome

Timeframe: May 2007

Population: Number of participants with suspected initial DVT with evaluable images

Outcome measures

Outcome measures
Measure	1 Hour Image Set n=29 Participants Review of whole leg 1 hour images	3 Hour Image Set n=29 Participants Review of 3 hour whole leg images	15 Min and 1 Hour Image Set n=29 Participants Review of whole leg 15 minute and 1 hour images in combination	15 Minute and 3 Hour Image Set n=29 Participants Review of whole leg 15 minute and 3 hour images in combination
To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT	93.1 % Specificity Interval 78.0 to 98.1	89.7 % Specificity Interval 73.6 to 96.4	100 % Specificity Interval 88.3 to 100.0	96.6 % Specificity Interval 82.8 to 99.4

SECONDARY outcome

Timeframe: May 2007

Population: Number of participants with suspected initial DVT with evaluable images

Outcome measures

Outcome measures
Measure	1 Hour Image Set n=22 Participants Review of whole leg 1 hour images	3 Hour Image Set n=22 Participants Review of 3 hour whole leg images	15 Min and 1 Hour Image Set n=22 Participants Review of whole leg 15 minute and 1 hour images in combination	15 Minute and 3 Hour Image Set n=22 Participants Review of whole leg 15 minute and 3 hour images in combination
To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT	18.2 % Sensitivity Interval 7.3 to 38.5	40.9 % Sensitivity Interval 23.3 to 61.3	0 % Sensitivity Interval 0.0 to 14.9	36.4 % Sensitivity Interval 19.7 to 57.1

SECONDARY outcome

Timeframe: May 2007

Outcome measures

Outcome data not reported

Adverse Events

Group 1

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

Dr Michael Gerometta

AGEN Biomedical Ltd

Phone: +61 408 885 416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60