Trial Outcomes & Findings for Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies (NCT NCT04258566)
NCT ID: NCT04258566
Last Updated: 2026-02-02
Results Overview
Number of Participants with detectable indocyanine green (ICG) fluorescent signal at the in-vivo site of biopsy using a combination of optical molecular imaging (OMI) and electromagnetic (EM) tracking. Real-time EM navigation effectively guided the needle to the vicinity of the target lesion, allowing subsequent OMI to be performed to provide in situ confirmation of ICG presence.
TERMINATED
NA
7 participants
Within 15 minutes from start of procedure
2026-02-02
Participant Flow
Participant milestones
| Measure |
Optical Plus Fusion for Liver Biopsy
Participants with diagnosed or suspected hepatocellular carcinoma (HCC) or metastatic intrahepatic cancer have the optical molecular imaging (OMI) performed with electromagnetic (EM) tracking during liver biopsy. Participants receive Indocyanine Green (ICG) 0.5 mg/kg, up to 40mg, intravenously 18-24hrs prior to scheduled biopsy.
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies
Baseline characteristics by cohort
| Measure |
Optical Plus Fusion for Liver Biopsy
n=7 Participants
Participants with diagnosed or suspected hepatocellular carcinoma (HCC) or metastatic intrahepatic cancer have the optical molecular imaging (OMI) performed with electromagnetic (EM) tracking during liver biopsy. Participants receive Indocyanine Green (ICG) 0.5 mg/kg, up to 40mg, intravenously 18-24hrs prior to scheduled biopsy.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=41 Participants
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Age, Categorical
Between 18 and 65 years
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4 Participants
n=41 Participants
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Age, Categorical
>=65 years
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3 Participants
n=41 Participants
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Sex: Female, Male
Female
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3 Participants
n=41 Participants
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Sex: Female, Male
Male
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4 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Asian
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3 Participants
n=41 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=41 Participants
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Race (NIH/OMB)
White
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1 Participants
n=41 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=41 Participants
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
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PRIMARY outcome
Timeframe: Within 15 minutes from start of procedurePopulation: All participants who completed the study.
Number of Participants with detectable indocyanine green (ICG) fluorescent signal at the in-vivo site of biopsy using a combination of optical molecular imaging (OMI) and electromagnetic (EM) tracking. Real-time EM navigation effectively guided the needle to the vicinity of the target lesion, allowing subsequent OMI to be performed to provide in situ confirmation of ICG presence.
Outcome measures
| Measure |
Optical Plus Fusion for Liver Biopsy
n=7 Participants
Participants with diagnosed or suspected hepatocellular carcinoma (HCC) or metastatic intrahepatic cancer have the optical molecular imaging (OMI) performed with electromagnetic (EM) tracking during liver biopsy. Participants receive Indocyanine Green (ICG) 0.5 mg/kg, up to 40mg, intravenously 18-24hrs prior to scheduled biopsy.
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Participants With Detectable Indocyanine Green (ICG) Fluorescent Signal at the In-vivo Site of Biopsy
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7 Participants
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SECONDARY outcome
Timeframe: Within 15 minutes from start of procedurePopulation: All participants who completed the study and was TBR positive.
The concordance with the histopathology and indocyanine green (ICG) fluorescent signal at the in-vivo site of biopsy using a combination of a handheld optical molecular imaging (OMI) and electromagnetic (EM) tracking and the target to background ratio (TBR) was obtained. Concordance is defined as a TBR ≥ 2. TBR is calculated by dividing the mean fluorescence intensity within the lesion by the mean fluorescence intensity within the adjacent liver parenchyma. Analysis was done as the median of all positive TBR readings.
Outcome measures
| Measure |
Optical Plus Fusion for Liver Biopsy
n=6 Participants
Participants with diagnosed or suspected hepatocellular carcinoma (HCC) or metastatic intrahepatic cancer have the optical molecular imaging (OMI) performed with electromagnetic (EM) tracking during liver biopsy. Participants receive Indocyanine Green (ICG) 0.5 mg/kg, up to 40mg, intravenously 18-24hrs prior to scheduled biopsy.
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|---|---|
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Concordance With the Histopathology and Indocyanine Green (ICG) Fluorescent Signal at the In-vivo Site of Biopsy Using a Combination of OMI and EM Tracking
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3.29 Ratio
Interval 2.47 to 35.96
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SECONDARY outcome
Timeframe: Within 15 minutes from start of procedurePopulation: All participants who completed the study.
Number of participants whose ex vivo fluorescence assessment of biopsy cores obtained from the target lesion is in concordance with the histopathology result from the same cores. The point-of-care device camera was used to confirmed the presence or absence of ICG emission in biopsy cores from all patients.
Outcome measures
| Measure |
Optical Plus Fusion for Liver Biopsy
n=7 Participants
Participants with diagnosed or suspected hepatocellular carcinoma (HCC) or metastatic intrahepatic cancer have the optical molecular imaging (OMI) performed with electromagnetic (EM) tracking during liver biopsy. Participants receive Indocyanine Green (ICG) 0.5 mg/kg, up to 40mg, intravenously 18-24hrs prior to scheduled biopsy.
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|---|---|
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Participants With Concordance Between Histopathology Outcomes and Target to Background Ratio (TBR) Using ex Vivo Fluorescence Assessment
Positive
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6 Participants
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Participants With Concordance Between Histopathology Outcomes and Target to Background Ratio (TBR) Using ex Vivo Fluorescence Assessment
Negative
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1 Participants
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Adverse Events
Optical Plus Fusion for Liver Biopsy
Serious adverse events
| Measure |
Optical Plus Fusion for Liver Biopsy
n=7 participants at risk
Participants with diagnosed or suspected hepatocellular carcinoma (HCC) or metastatic intrahepatic cancer have the optical molecular imaging (OMI) performed with electromagnetic (EM) tracking during liver biopsy. Participants receive Indocyanine Green (ICG) 0.5 mg/kg, up to 40mg, intravenously 18-24hrs prior to scheduled biopsy.
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General disorders
Infusion related reaction
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14.3%
1/7 • 18-24 hours before before procedure and up to three hours post procedure
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place