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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
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 below
I have liver cancer or tumors and need a biopsy.
I have a tumor that can be easily biopsied.
I am post-menopausal or not currently pregnant.
I am older than 18 years.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~liver parenchyma, target lesion, ex vivo
This trial's timeline: 3 weeks for screening, Varies for treatment, and liver parenchyma, target lesion, ex vivo for reporting.

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
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine Green
Completed Phase 2

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

Optical Molecular Imaging (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT04258566 — Phase 1
Liver Cancer Research Study Groups: Suspected hepatic malignancy
Liver Cancer Clinical Trial 2023: Optical Molecular Imaging Highlights & Side Effects. Trial Name: NCT04258566 — Phase 1
Optical Molecular Imaging (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04258566 — Phase 1

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
~16 spots leftby Dec 2024