Hepatocellular CarcinomaEarly Phase 1NCT01962649
A Pilot Study of Optical Molecular Imaging for Percutaneous Biopsy of Hepatocellular Carcinoma Using Indocyanine Green
A Early Phase 1 study testing ICG and Optical molecular imaging in people with Hepatocellular Carcinoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is evaluating an imaging contrast agent called indocyanine green, also known as ICG, in combination with image guided liver biopsies. In this research study, the investigators are looking at the ability of ICG to collect within liver tumors during biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- ICG and Optical molecular imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Apr 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must be patients with imaging findings revealing a focal hepatic lesion suspicious for but not diagnostic of hepatocellular carcinoma. Eligible patients will be those whose imaging demonstrates an incompletely characterized focal hepatic lesion for which either ultrasound- or CT-guided biopsy is planned.
- For the negative control study, participants must be patients without known malignancy for whom either ultrasound- or CT-guided non-focal liver biopsy is planned to evaluate a non-malignant process.
- Fit for conscious sedation for percutaneous biopsy - American Society of Anesthesiologists (ASA) Class I or II.
- Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of ICG in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric Phase I trials.
- Life expectancy of greater than 6 months.
Show all 13Show fewer
- ECOG performance status <2 (see Appendix A).
- Participants must have normal organ and marrow function as defined below:
- Leukocytes > 3,000/mcL
- Absolute neutrophil count > 1,500/mcL
- Platelets > 50,000/mcL
- The effects of ICG on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants with ASA class III, IV, V.
- Participants with documented allergy to iodine or iodine containing compounds.
- Participants with documented allergy to sulfur containing compounds.
- History of adverse reactions to percutaneous procedures or sedatives for endoscopy or percutaneous biopsy.
- Participants taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, and probenecid.
Show all 10Show fewer
- Participants who are unable to discontinue warfarin and clopidogrel anticoagulation 5 days prior to the procdure.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because there are unknown but potential teratogenic or abortifacient effects of ICG. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with ICG, breastfeeding should be discontinued if the mother is treated with ICG. These potential risks may also apply to other agents used in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This research study is evaluating an imaging contrast agent called indocyanine green, also known as ICG, in combination with image guided liver biopsies.
In this research study, the investigators are looking at the ability of ICG to collect within liver tumors during biopsy. The participant will be receiving a biopsy of their liver as a part of their medical care. By participating in this trial, the only additional requirement will be for the participant to come to the hospital on the day prior to their scheduled biopsy to receive an injection of ICG. During the biopsy, the investigator will measure the amount of ICG that is in the participant's liver tumor by using two experimental devices designed by the study investigators that shine light on tissue. One device consists of an imaging system attached to a small borescope that will go inside the participant's body during the biopsy. The second device shines light on the biopsy sample outside of the participant's body after the biopsy has been taken. The participant may undergo imaging with one or both of these devices.
Read the detailed description
Before the research starts (screening): After signing this consent form, the participant will be asked to undergo some screening tests or procedures to find out if the participant can be in the research study. Many of these tests and procedures are likely to be part of regular care and may be done even if it turns out that the participant does not take part in the research study. If the participant has had some of these tests or procedures recently, they may or may not have to be repeated.
- A medical history, which includes questions about the participant's health, current medications, and any allergies.
- Performance status, which evaluates how the participant is able to carry on with their usual activities.
- An assessment of your liver by X-ray, ultrasound, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans.
- Anesthesia score, which evaluates how the participant tolerates the sedation given with biopsies.
- Blood tests.
If these tests show that the participant is eligible to participate in the research study, the participant will receive the study agent. If the participant does not meet the eligibility criteria, then the participant will not be able to participate in this research study.
After the screening procedures confirms that the participant is eligible to participate in the research study: The participant will be scheduled for their regular CT- or ultrasound-guided liver biopsy. On the day prior to the procedure, the participant will come to our Interventional Radiology waiting area at Massachusetts General Hospital. After the participant arrives, the participant will be interviewed by a research doctor and receive a dose of ICG intravenously. The participant will be monitored for 30 minutes after the injection, and after this time, the participant will be free to leave. On the day of the procedure, the participant will come back to the Interventional Radiology waiting area. After the participant arrives, the participant will receive an intravenous line. The participant may also have some blood drawn (no more that 4 tablespoons) for any tests needed in addition to blood work done before the participant was enrolled in the study. The participant will then meet again with the research doctor, who will go over the procedure with the participant and as usual obtain their consent to have the standard liver biopsy. The nurse will begin administering the sedatives until the participant is comfortable to proceed with the procedure. The research doctor and his assistant will advance a hollow biopsy needle through the skin and into the lesion in the liver. A miniature endoscope, small enough to fit through the hollow center of the biopsy needle, will then be passed through the needle so that the tip of the endoscope is within the lesion. The fluorescence within the lesion will be measured with the endoscope by a special camera attached to the back of the endoscope. The endoscope will then be removed, and the lesion will be biopsied with a standard biopsy needle. If the participant is undergoing a biopsy of the liver to obtain a sample of their liver tissue and not a specific area in the liver, the endoscopic imaging described above will not be performed. The biopsy will be performed in the usual way. Once the biopsy is performed, the sample of tissue from the biopsy will be imaged by a special camera and computer that will be within the procedure room. The added steps for this trial should only add approximately 5 minutes to the procedure time.
After the procedure: After the procedure is complete, the investigator will bring the participant to the recovery room so that the participant can sleep off the sedative medications. Throughout this time, the participant will be observed by a nurse, and vital signs will be monitored. The participant will be given the usual post-procedure instructions. The investigator would like to keep track of your medical condition after the procedure to make sure no side effects have occurred. The investigator would like to do this by calling the participant on the telephone the day after the procedure and 1 week after the procedure.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- ICG, Optical molecular imaging
- Keywords
- Hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICGBiological
Also called IC-Green
Optical molecular imagingDevice
Also called OMI
| Study group | Role | What they receive |
|---|---|---|
| ICG & Optical Molecular Imaging | Experimental | All patients will receive a dose of ICG 0.5mg/kg, with a maximum dose of 40mg, one day prior to the scheduled procedure. The patients will then undergo a routine image-guided biopsy on the day of the procedure; immediately prior to obtaining the biopsy sample, fluorescence intensity within the target lesion will be measured by a handheld optical molecular imaging device, which will be passed through the biopsy needle. Once the core sample is obtained using a standard biopsy needle, the specimen will be imaged using an epifluorescence, point-of-care imaging system and will then be submitted for standard pathologic analysis. Receives: Biological: ICG; Device: Optical molecular imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of fluorescence intensity within focal hepatic lesions
We hypothesize that HCC lesions will have significantly higher fluorescence intensity following ICG administration that normal/cirrhotic liver parenchyma. This will allow the proceduralist to recognize during the procedure whether the target lesion has been sampled accurately. We also hypothesize that OMI will characterize malignant lesions with >90% accuracy prior to core biopsy, with standard of care histology and follow up imaging as the gold standard. Benign and malignant lesions will have significantly different ICG uptake to allow for their differentiation based on their ICG fluorescence signal intensity measured percutaneously.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America
- Responsible party
- Principal investigator, Umar Mahmood, Massachusetts General Hospital
- Investigators
- Umar Mahmood, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962649
- Sponsor's protocol ID
- 13-314
- Status last verified
- Apr 2018
- First submitted
- 10 Oct 2013
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Optical Molecular Imaging for Percutaneous Biopsy of Hepatocellular Carcinoma Using Indocyanine Green
- ClinicalTrials.gov ID
- NCT01962649
- Acronym / sponsor ID
- 13-314
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Radiological Society of North America
- Study start
- Oct 2013 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating an imaging contrast agent called indocyanine green, also known as ICG, in combination with image guided liver biopsies.
In this research study, the investigators are looking at the ability of ICG to collect within liver tumors during biopsy. The participant will be receiving a biopsy of their liver as a part of their medical care. By participating in this trial, the only additional requirement will be for the participant to come to the hospital on the day prior to their scheduled biopsy to receive an injection of ICG. During the biopsy, the investigator will measure the amount of ICG that is in the participant's liver tumor by using two experimental devices designed by the study investigators that shine light on tissue. One device consists of an imaging system attached to a small borescope that will go inside the participant's body during the biopsy. The second device shines light on the biopsy sample outside of the participant's body after the biopsy has been taken. The participant may undergo imaging with one or both of these devices.
Detailed description
Before the research starts (screening): After signing this consent form, the participant will be asked to undergo some screening tests or procedures to find out if the participant can be in the research study. Many of these tests and procedures are likely to be part of regular care and may be done even if it turns out that the participant does not take part in the research study. If the participant has had some of these tests or procedures recently, they may or may not have to be repeated.
- A medical history, which includes questions about the participant's health, current medications, and any allergies.
- Performance status, which evaluates how the participant is able to carry on with their usual activities.
- An assessment of your liver by X-ray, ultrasound, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans.
- Anesthesia score, which evaluates how the participant tolerates the sedation given with biopsies.
- Blood tests.
If these tests show that the participant is eligible to participate in the research study, the participant will receive the study agent. If the participant does not meet the eligibility criteria, then the participant will not be able to participate in this research study.
After the screening procedures confirms that the participant is eligible to participate in the research study: The participant will be scheduled for their regular CT- or ultrasound-guided liver biopsy. On the day prior to the procedure, the participant will come to our Interventional Radiology waiting area at Massachusetts General Hospital. After the participant arrives, the participant will be interviewed by a research doctor and receive a dose of ICG intravenously. The participant will be monitored for 30 minutes after the injection, and after this time, the participant will be free to leave. On the day of the procedure, the participant will come back to the Interventional Radiology waiting area. After the participant arrives, the participant will receive an intravenous line. The participant may also have some blood drawn (no more that 4 tablespoons) for any tests needed in addition to blood work done before the participant was enrolled in the study. The participant will then meet again with the research doctor, who will go over the procedure with the participant and as usual obtain their consent to have the standard liver biopsy. The nurse will begin administering the sedatives until the participant is comfortable to proceed with the procedure. The research doctor and his assistant will advance a hollow biopsy needle through the skin and into the lesion in the liver. A miniature endoscope, small enough to fit through the hollow center of the biopsy needle, will then be passed through the needle so that the tip of the endoscope is within the lesion. The fluorescence within the lesion will be measured with the endoscope by a special camera attached to the back of the endoscope. The endoscope will then be removed, and the lesion will be biopsied with a standard biopsy needle. If the participant is undergoing a biopsy of the liver to obtain a sample of their liver tissue and not a specific area in the liver, the endoscopic imaging described above will not be performed. The biopsy will be performed in the usual way. Once the biopsy is performed, the sample of tissue from the biopsy will be imaged by a special camera and computer that will be within the procedure room. The added steps for this trial should only add approximately 5 minutes to the procedure time.
After the procedure: After the procedure is complete, the investigator will bring the participant to the recovery room so that the participant can sleep off the sedative medications. Throughout this time, the participant will be observed by a nurse, and vital signs will be monitored. The participant will be given the usual post-procedure instructions. The investigator would like to keep track of your medical condition after the procedure to make sure no side effects have occurred. The investigator would like to do this by calling the participant on the telephone the day after the procedure and 1 week after the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG & Optical Molecular Imaging | Experimental | Biological: ICG, Device: Optical molecular imagingAll patients will receive a dose of ICG 0.5mg/kg, with a maximum dose of 40mg, one day prior to the scheduled procedure. The patients will then undergo a routine image-guided biopsy on the day of the procedure; immediately prior to obtaining the biopsy sample, fluorescence intensity within the target lesion will be measured by a handheld optical molecular imaging device, which will be passed through the biopsy needle. Once the core sample is obtained using a standard biopsy needle, the specimen will be imaged using an epifluorescence, point-of-care imaging system and will then be submitted for standard pathologic analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must be patients with imaging findings revealing a focal hepatic lesion suspicious for but not diagnostic of hepatocellular carcinoma. Eligible patients will be those whose imaging demonstrates an incompletely characterized focal hepatic lesion for which either ultrasound- or CT-guided biopsy is planned.
- For the negative control study, participants must be patients without known malignancy for whom either ultrasound- or CT-guided non-focal liver biopsy is planned to evaluate a non-malignant process.
- Fit for conscious sedation for percutaneous biopsy - American Society of Anesthesiologists (ASA) Class I or II.
- Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of ICG in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric Phase I trials.
Key exclusion criteria (10 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants with ASA class III, IV, V.
- Participants with documented allergy to iodine or iodine containing compounds.
- Participants with documented allergy to sulfur containing compounds.
- History of adverse reactions to percutaneous procedures or sedatives for endoscopy or percutaneous biopsy.
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 |
|---|---|---|
| ICGAlso: IC-Green | Biological | ICG & Optical Molecular Imaging |
| Optical molecular imagingAlso: OMI | Device | ICG & Optical Molecular Imaging |
Primary outcome
Measurement of fluorescence intensity within focal hepatic lesions
Time frame: 2 Years
We hypothesize that HCC lesions will have significantly higher fluorescence intensity following ICG administration that normal/cirrhotic liver parenchyma. This will allow the proceduralist to recognize during the procedure whether the target lesion has been sampled accurately. We also hypothesize that OMI will characterize malignant lesions with >90% accuracy prior to core biopsy, with standard of care histology and follow up imaging as the gold standard. Benign and malignant lesions will have significantly different ICG uptake to allow for their differentiation based on their ICG fluorescence signal intensity measured percutaneously.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Umar Mahmood, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ICG and Optical molecular imaging in people with Hepatocellular Carcinoma, run by Massachusetts General Hospital 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 13 inclusion and 10 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: finished, as of the sponsor's last update on 25 Apr 2018. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of fluorescence intensity within focal hepatic lesions (time frame: 2 Years). 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 25 Apr 2018.