Trial Outcomes & Findings for Computer Assisted Volumetric Analysis of CT-Identified Metastatic Pulmonary Or Hepatic Lesions (NCT NCT00676455)

Results Overview

Due to the low enrollment for this project the data collected is not sufficient to provide any significant conclusion to the primary outcome hypothesis. Due to lack of participants. No significant findings are reported at this time.

Recruitment status

TERMINATED

Target enrollment

14 participants

Primary outcome timeframe

As long as treatment is being assessed by CT examinations

Results posted on

2013-05-10

Participant Flow

Approximately 100 participants were to be enrolled, with approximately 50 of each type of metastatic disease. 50 participants with metastatic Liver tumors and 50 with metastatic Lung tumors.

Participant milestones

Participant milestones
Measure	Metastatic Lung and Liver Tumor Growth Measurement This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Computer Assisted Volumetric Analysis of CT-Identified Metastatic Pulmonary Or Hepatic Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metastatic Lung and Liver Tumor Growth Measurement n=14 Participants This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	14 participants n=99 Participants

PRIMARY outcome

Timeframe: As long as treatment is being assessed by CT examinations

Population: Due to low enrollment no analysis was conducted due to the lack of participants.

Due to the low enrollment for this project the data collected is not sufficient to provide any significant conclusion to the primary outcome hypothesis. Due to lack of participants. No significant findings are reported at this time.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: As long as treatment is being assessed by CT examinations

Population: Due to low enrollment no analysis was conducted due to the lack of participants.

Tumor size will be measured by CT (by the MeVis Volumetry Software and correlated with on-going treatment plan. Correlation of the tumor growth with clinical treatment will be assessed. Tumor size will be expressed in volume. Specifically Three dimensional volume Volume of Interest(VOI)will be calculated and correlated with the treatment protocol. Measure = tumor volume.

Outcome measures

Outcome data not reported

Adverse Events

Metastatic Lung and Liver Tumor Growth Measurement

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

Christopher Wald, MD

Lahey Clinic

Phone: 781-744-8710

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place