Trial Outcomes & Findings for Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI. (NCT NCT00539253)

Results Overview

Maximal nodule size measured in centimeters

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

3 months

Results posted on

2017-09-26

Participant Flow

January, 2008 to May, 2012 People with hepatocellular carcinoma who were candidates for TACE who were referred to Johns Hopkins Hospital.

none observed

Participant milestones

Participant milestones
Measure	Gadabenate Dimeglumine( Multihance) If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MRI imaging for both the baseline and 1 month f/u studies.
Overall Study STARTED	45
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gadobenate Dimeglumine (Multi Hance) n=45 Participants If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
Age, Continuous	60.9 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The number of participants analyzed reflects the number of participants for whom data was available.

Maximal nodule size measured in centimeters

Outcome measures

Outcome measures
Measure	Multihance n=19 Participants If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
Nodule Size	6.4 centimeters Standard Deviation 4.5

PRIMARY outcome

Timeframe: 3 month

Population: Number of participants analyzed reflects the number of participants for whom data was available

Percent area of nodule with enhancement

Outcome measures

Outcome measures
Measure	Multihance n=19 Participants If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
Nodule Enhancement	32.8 percent enhancement Standard Deviation 30.7

Adverse Events

Gadobenate Dimeglumine (Multi Hance)

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

Ihab R. Kamel, M.D. PhD

Johns Hopkins Hospital

Phone: 410-955-4567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place