Fusion Imaging + Optical Imaging for Liver Biopsies

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institutes of Health Clinical Center (CC)

Disqualifiers: Pregnancy, Nursing, Hypersensitivity, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance liver biopsies by combining fusion imaging and optical molecular imaging to more accurately locate and sample areas of concern in the liver. This approach helps determine the presence and type of liver cancer. The trial seeks individuals who require a liver biopsy as part of their diagnosis or treatment plan. Participants will undergo imaging, a physical exam, and a biopsy procedure guided by advanced imaging technology. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to benefit from this innovative approach.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that combining fusion imaging and optical imaging is safe for liver biopsies?

Research shows that a special imaging technique using the dye indocyanine green (ICG) is safe for liver procedures. This method enhances the visibility of liver tissues, aiding doctors in locating tumors more easily.

ICG is commonly used in surgeries and is well-tolerated by patients. Studies indicate that this imaging technique can accurately identify liver tumors, with success rates between 85% and 100%. This demonstrates its effectiveness in finding tumors without causing harm.

Overall, using this imaging method with ICG in liver biopsies appears safe. Previous research reports no major side effects, and participants have tolerated the procedure well, indicating its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using optical molecular imaging for liver biopsies because it offers a new way to pinpoint malignant lesions in the liver with greater accuracy. Unlike standard imaging techniques like ultrasound or CT scans, which provide structural images, optical molecular imaging highlights molecular changes, offering a more detailed view of potential cancerous areas. This method can lead to more precise biopsies, potentially increasing the accuracy of diagnosis and improving patient outcomes by ensuring that malignancies are identified early and accurately.

What evidence suggests that combining fusion imaging and optical imaging is effective for liver biopsies?

This trial will use optical molecular imaging (OMI) with the dye indocyanine green to assist in liver biopsies. Studies have shown that OMI effectively finds liver tumors, with an 85% to 100% success rate in detecting tumors on the liver's surface. This makes it highly effective at identifying problem areas during liver surgeries. Evidence from previous patients shows that OMI can lead to better outcomes both immediately after surgery and in the long term. Combining OMI with other advanced imaging techniques may help doctors obtain better samples for diagnosing liver cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Bradford J Wood, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

I do not have any severe illnesses that would stop me from following the study's requirements.

You have had allergic reactions in the past to certain dyes used in medical tests or to substances containing sulfur.

Pregnant women and nursing mothers are excluded from this study because of exposure to radiation from CT scanning associated with the biopsy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-Biopsy Preparation

Participants will have a dye injected into a vein 24 hours before their biopsy and will be monitored for 30 minutes for any side effects.

1 day

1 visit (in-person)

Biopsy Procedure

Participants undergo a liver biopsy with the aid of electromagnetic tracking and optical imaging. They will have a CT scan to plan the needle's pathway and a small camera will be placed near the needle to take pictures of the liver.

1 day

1 visit (in-person)

Post-Biopsy Recovery

Participants will recover in the hospital for 4-6 hours after the biopsy procedure.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the biopsy procedure.

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Indocyanine Green
• Optical Molecular Imaging

Trial Overview 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.

How Is the Trial Designed?

Group I: Suspected hepatic malignancy Experimental Treatment 2 Interventions

Malignancy determination of new onset hepatic lesion

Who Is Running the Clinical Trial?

National Institutes of Health Clinical Center (CC)

Lead Sponsor

Trials

391

Recruited

30,880,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8384721/

Electromagnetic Tracking and Optical Molecular Imaging ... OMI has been used to characterize liver tissue as benign or malignant during biopsy and surgery (4, 5). OMI can be combined with intravascular injection of a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10027802/

Short- and Long-Term Outcomes of Indocyanine Green ... Is a fluorescence navigation system with indocyanine green effective enough to detect liver malignancies? J Hepatobiliary Pancreat Sci. 2014 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1572100023002247

A meta-analysis of short-term and long-term effects ... Indocyanine green fluorescence imaging has good clinical value and can improve the short-term and long-term results of hepatectomy for liver cancer.

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1167536/full

Application of indocyanine green-mediated fluorescence ... Some published data suggest that the sensitivity of ICG fluorescence imaging to identify superficial liver tumor was 85% (44) to 100% (11).

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04258566

Electromagnetic Tracking and Optical Imaging With ICG for ... Pilot study to evaluate the combination of optical molecular imaging (OMI) and EM tracking in localizing intrahepatic lesions and assess the concordance between ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1572100021001812

Meta-analysis of indocyanine green fluorescence imaging ... This study compares the effectiveness and safety of ICG fluorescence imaging guided laparoscopic hepatectomy. •. The results provide a large sample for ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2817838

ICG-Fluorescence Imaging for Margin Assessment During ... The findings of this study suggest that ICG fluorescence may provide surgeons with real-time feedback of the tumor margin during minimally invasive surgery.