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Imaging
Fusion Imaging + Optical Imaging for Liver Biopsies
Phase 1
Waitlist Available
Led By Bradford J Wood, M.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 IRB-approved under a separate research protocol
Patients must have at least one lesion that can readily be biopsied per Principal Investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post biopsy
Awards & highlights
Study Summary
This trial is testing whether using fusion imaging and optical imaging can provide a better liver sample than using CT imaging alone.
Who is the study for?
This trial is for adults who need a liver biopsy and may have hepatocellular carcinoma or other liver tumors. They must be able to consent, not pregnant, and without severe allergies to ICG or iodine-based contrasts. Those with serious illnesses that could limit study compliance are excluded.Check my eligibility
What is being tested?
The study tests if combining electromagnetic tracking (a medical GPS) with optical imaging using Indocyanine Green dye improves liver biopsies. Participants will undergo CT scans and use a camera-guided needle for the biopsy procedure.See study design
What are the potential side effects?
Potential side effects include reactions to the Indocyanine Green dye such as allergy symptoms, issues from the CT scan like radiation exposure, discomfort from the needle during biopsy, and standard risks associated with any invasive procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have liver cancer or tumors and need a biopsy.
Select...
I have a tumor that can be easily biopsied.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ liver parenchyma, target lesion, ex vivo
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~liver parenchyma, target lesion, ex vivo
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ICG Fluorescene
Secondary outcome measures
Exvivo fluorescence
In vivo fluorescence
Trial Design
1Treatment groups
Experimental Treatment
Group I: Suspected hepatic malignancyExperimental Treatment2 Interventions
Malignancy determination of new onset hepatic lesion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine Green
2008
Completed Phase 2
~1050
Find a Location
Who is running the clinical trial?
National Institutes of Health Clinical Center (CC)Lead Sponsor
383 Previous Clinical Trials
881,121 Total Patients Enrolled
13 Trials studying Liver Cancer
554 Patients Enrolled for Liver Cancer
Bradford J Wood, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
7 Previous Clinical Trials
4,001 Total Patients Enrolled
3 Trials studying Liver Cancer
48 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have liver cancer or tumors and need a biopsy.I have a tumor that can be easily biopsied.I do not have any severe illnesses that would stop me from following the study's requirements.I am post-menopausal or not currently pregnant.You have had allergic reactions in the past to certain dyes used in medical tests or to substances containing sulfur.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: Suspected hepatic malignancy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for participants in this experiment?
"Unfortunately, clinicaltrials.gov reports that this trial is not enrolling patients presently. Initially posted on January 27th 2022 and last updated August 6th 2022, the study has no current vacancies; however, there are currently 664 other trials actively recruiting participants."
Answered by AI
Could you elaborate on the safety of Optical Molecular Imaging for patients?
"With minimal data on its efficacy and safety, our team at Power assigned Optical Molecular Imaging a score of 1."
Answered by AI
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