Hepatocellular CarcinomaNCT04258566
Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies
A study testing Optical Molecular Imaging (OMI), Indocyanine Green (ICG) and Electromagnetic Tracking in people with Hepatocellular Carcinoma, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Liver cancer is the sixth most common cancer worldwide. Diagnosing liver cancer usually requires a liver sample. Getting the best sample helps determine whether cancer is present and what kind of cancer it is. But sampling can be difficult. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Optical Molecular Imaging (OMI), Indocyanine Green (ICG) and Electromagnetic Tracking
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2022to 29 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order be eligible to participate in this study, an individual must meet all of the following criteria:
- Patients must have imaging findings consistent with hepatocellular carcinoma or other liver neoplasms or metastasis, for whom image-guided percutaneous biopsy is planned as clinically indicated or Institutional Review Board (IRB)-approved under a separate research protocol.
- Patients must have at least one lesion that can readily be biopsied per Principal Investigator.
- Age >18 years.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they verbally report amenorrhea for 12 months without an alternative medical cause, or have had surgery or received chemicals to induce menopause.
Who cannot join
- History of hypersensitivity reactions to Indocyanine Green (ICG), iodinated contrast, or sulfur-containing compounds.
- Pregnant women and nursing mothers are excluded from this study because of exposure to radiation from CT scanning associated with the biopsy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the Principal Investigator, would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Feasibility Study to Evaluate the Combination of Electromagnetic Tracking and Optical Imaging With Indocyanine Green (ICG) for Hepatic Biopsies
Background:
Liver cancer is the sixth most common cancer worldwide. Diagnosing liver cancer usually requires a liver sample. Getting the best sample helps determine whether cancer is present and what kind of cancer it is. But sampling can be difficult. This study will look at combining two devices to provide better liver samples.
Read more
Objective:
To see if combining fusion imaging and optical imaging can better sample areas of concern in the liver and determine the presence of disease.
Eligibility:
People ages 18 and older who need a liver biopsy as part of diagnosis or treatment.
Design:
Participants will be screened with:
- Review of imaging
- Medical history
- Physical exam
- Blood test results
Participants will have a dye injected into a vein 24 hours before their biopsy. They will be monitored for 30 minutes for any side effects.
For the biopsy, participants skin will be numbed. They may have stickers placed on their belly to help guide the needle. They will have a CT scan to plan the needle s pathway. For the scan, they will lie in a machine that takes pictures of the body. A small camera will be placed near the needle to take pictures of the liver. A medical global positioning system (GPS) tracking system will be used. This will guide the needle into the area of the participant s liver where the biopsy will be taken.
After the biopsy, participants will recover in the hospital for 4 6 hours.
After the procedure, researchers will take the participants biopsy tissue and look at it to try to compare new ways to picture the sample.
Read the detailed description
- Pilot study to evaluate the combination of optical molecular imaging (OMI) and EM tracking in localizing intrahepatic lesions and assess the concordance between fluorescence ICG and histopathology for the diagnosis of liver cancer.
- Hepatocellular Carcinoma (HCC) is the 3rd most common cause of cancer globally with an increasing incidence worldwide. Percutaneous sampling of focal hepatic lesions is a cornerstone in management of patients with hepatic pathology. In a retrospective study of patients with small hepatic lesions, up to 45% of the lesions biopsied were insufficiently visualized and resulted to a false negative rate (defined as patients with benign biopsies who were subsequently found to have malignant lesions at the attempted site of biopsy). Thirty seven percent of those were for HCC.
- EM navigation and fusion of real-time images with pre-acquired scans has been used in hepatic biopsies at the NIH for more than 15 years. NIH / NCI clinical trials have performed fusion biopsies with EM tracking in > 2000 patients, > 40,000 biopsies over the past 12 years.
- Indocyanine green (ICG) is an FDA approved optical molecular imaging fluorescent dye used for visualization of cells and tissues. ICG has been used for decades in ophthalmology for imaging retinal blood vessels. ICG was FDA cleared in 1959 and has been widely used to assess liver function perioperatively. ICG is administered as an injection. Adverse effects are rare and most often minor.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Optical Molecular Imaging (OMI), Indocyanine Green (ICG), Electromagnetic Tracking
- Keywords
- Hepatic Carcinoma, Indocyanine Green (ICG), Optical Imaging
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Molecular Imaging (OMI)Device
Tracks and localizes intrahepatic lesions
Indocyanine Green (ICG)Radiation
Fluorescent dye used for visualization of cells and tissue
Electromagnetic TrackingDevice
Tracks and localizes intrahepatic lesions
| Study group | Role | What they receive |
|---|---|---|
| Optical plus fusion for liver biopsy | Experimental | 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. Receives: Device: Optical Molecular Imaging (OMI); Radiation: Indocyanine Green (ICG); Device: Electromagnetic Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Detectable Indocyanine Green (ICG) Fluorescent Signal at the In-vivo Site of Biopsy
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.
Measured: Within 15 minutes from start of procedure
Secondary outcomes (2)
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
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.
Measured: Within 15 minutes from start of procedure
Participants With Concordance Between Histopathology Outcomes and Target to Background Ratio (TBR) Using ex Vivo Fluorescence Assessment
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.
Measured: Within 15 minutes from start of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start27 Jan 2022
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Why it stopped: Recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter A Pinto, M.D., Principal investigator, National Institutes of Health National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258566
- Sponsor's protocol ID
- 200039
- Other IDs
- 20-CC-0039
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2020
- Last updated
- 2 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified human data generated in this research for future research may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the Combination of Electromagnetic Tracking and Optical Imaging With Indocyanine Green (ICG) for Hepatic Biopsies
- ClinicalTrials.gov ID
- NCT04258566
- Acronym / sponsor ID
- 200039
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatic Carcinoma, Indocyanine Green (ICG), Optical Imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulty
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Posted 2 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Liver cancer is the sixth most common cancer worldwide. Diagnosing liver cancer usually requires a liver sample. Getting the best sample helps determine whether cancer is present and what kind of cancer it is. But sampling can be difficult. This study will look at combining two devices to provide better liver samples.
Objective:
To see if combining fusion imaging and optical imaging can better sample areas of concern in the liver and determine the presence of disease.
Eligibility:
People ages 18 and older who need a liver biopsy as part of diagnosis or treatment.
Design:
Participants will be screened with:
- Review of imaging
- Medical history
- Physical exam
- Blood test results
Participants will have a dye injected into a vein 24 hours before their biopsy. They will be monitored for 30 minutes for any side effects.
For the biopsy, participants skin will be numbed. They may have stickers placed on their belly to help guide the needle. They will have a CT scan to plan the needle s pathway. For the scan, they will lie in a machine that takes pictures of the body. A small camera will be placed near the needle to take pictures of the liver. A medical global positioning system (GPS) tracking system will be used. This will guide the needle into the area of the participant s liver where the biopsy will be taken.
After the biopsy, participants will recover in the hospital for 4 6 hours.
After the procedure, researchers will take the participants biopsy tissue and look at it to try to compare new ways to picture the sample.
Detailed description
- Pilot study to evaluate the combination of optical molecular imaging (OMI) and EM tracking in localizing intrahepatic lesions and assess the concordance between fluorescence ICG and histopathology for the diagnosis of liver cancer.
- Hepatocellular Carcinoma (HCC) is the 3rd most common cause of cancer globally with an increasing incidence worldwide. Percutaneous sampling of focal hepatic lesions is a cornerstone in management of patients with hepatic pathology. In a retrospective study of patients with small hepatic lesions, up to 45% of the lesions biopsied were insufficiently visualized and resulted to a false negative rate (defined as patients with benign biopsies who were subsequently found to have malignant lesions at the attempted site of biopsy). Thirty seven percent of those were for HCC.
- EM navigation and fusion of real-time images with pre-acquired scans has been used in hepatic biopsies at the NIH for more than 15 years. NIH / NCI clinical trials have performed fusion biopsies with EM tracking in > 2000 patients, > 40,000 biopsies over the past 12 years.
- Indocyanine green (ICG) is an FDA approved optical molecular imaging fluorescent dye used for visualization of cells and tissues. ICG has been used for decades in ophthalmology for imaging retinal blood vessels. ICG was FDA cleared in 1959 and has been widely used to assess liver function perioperatively. ICG is administered as an injection. Adverse effects are rare and most often minor.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical plus fusion for liver biopsy | Experimental | Device: Optical Molecular Imaging (OMI), Radiation: Indocyanine Green (ICG), Device: Electromagnetic TrackingParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In order be eligible to participate in this study, an individual must meet all of the following criteria:
- Patients must have imaging findings consistent with hepatocellular carcinoma or other liver neoplasms or metastasis, for whom image-guided percutaneous biopsy is planned as clinically indicated or Institutional Review Board (IRB)-approved under a separate research protocol.
- Patients must have at least one lesion that can readily be biopsied per Principal Investigator.
- Age >18 years.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- History of hypersensitivity reactions to Indocyanine Green (ICG), iodinated contrast, or sulfur-containing compounds.
- Pregnant women and nursing mothers are excluded from this study because of exposure to radiation from CT scanning associated with the biopsy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the Principal Investigator, would limit compliance with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Molecular Imaging (OMI)Tracks and localizes intrahepatic lesions | Device | Optical plus fusion for liver biopsy |
| Indocyanine Green (ICG)Fluorescent dye used for visualization of cells and tissue | Radiation | Optical plus fusion for liver biopsy |
| Electromagnetic TrackingTracks and localizes intrahepatic lesions | Device | Optical plus fusion for liver biopsy |
Primary outcome
Participants With Detectable Indocyanine Green (ICG) Fluorescent Signal at the In-vivo Site of Biopsy
Time frame: Within 15 minutes from start of procedure
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.
2 secondary outcomes
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
Time frame: Within 15 minutes from start of procedure
Participants With Concordance Between Histopathology Outcomes and Target to Background Ratio (TBR) Using ex Vivo Fluorescence Assessment
Time frame: Within 15 minutes from start of procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified human data generated in this research for future research may be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A Pinto, M.D. principal investigator
National Institutes of Health National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Molecular Imaging (OMI), Indocyanine Green (ICG) and Electromagnetic Tracking in people with Hepatocellular Carcinoma, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Detectable Indocyanine Green (ICG) Fluorescent Signal at the In-vivo Site of Biopsy (time frame: Within 15 minutes from start of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.