Targeted Navigation for Liver Cancer

Overseen by Patricia Jones, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Miami

Disqualifiers: Non-English/Spanish speakers, Cognitive impairment, Minors, Prisoners, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Target Navigation Pilot Program treatment for liver cancer?

Research shows that patient navigation programs, which help guide patients through cancer treatment, have been effective in improving care coordination and increasing participation in cancer screening and follow-up care. These programs have shown some success in other types of cancer, suggesting potential benefits for liver cancer patients as well. ^{1 2 3 4 5}

Is the Targeted Navigation for Liver Cancer treatment safe for humans?

The safety of navigation systems for liver cancer treatments, like thermal ablation and radiofrequency ablation, has been evaluated, showing that these techniques aim to enhance treatment precision and safety. Studies have assessed the safety of these methods, indicating they are generally safe for use in humans. ^{6 7 8 9 10}

How is the Target Navigation Pilot Program treatment different from other liver cancer treatments?

The Target Navigation Pilot Program is unique because it uses advanced navigation technology to precisely target liver tumors, which can improve the accuracy and safety of treatments like microwave ablation. This approach is particularly beneficial for tumors that are hard to detect with traditional imaging methods, offering a more precise and minimally invasive option compared to conventional treatments. ^{6 7 8 11 12}

Research Team

Patricia Jones, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for individuals with liver cancer, including hepatocellular carcinoma and bile duct cancer. It's focused on understanding patient needs during diagnosis and treatment to improve care.

Inclusion Criteria

Able to provide informed consent

Others who self-identify as either a caregiver or support person of an HCC patient

HCC Patients: Enrolled or eligible for enrollment in Unified Prospective Registry and Biorepository of Patients with Chronic Liver Disease or Hepatobiliary Cancers Including Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma

Exclusion Criteria

Pregnant women

Prisoners

Adults unable or unwilling to consent

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Targeted Navigation Pilot Program

Participants are enrolled in a Targeted Navigation Pilot Program to assist with navigating the process of being diagnosed with liver cancer and receiving treatment

12 months

Follow-up

Participants are monitored for outcomes such as enrollment in clinical research and time to first contact, appointment, and treatment

4 weeks

Treatment Details

Interventions

• Target Navigation Pilot Program (Behavioral Intervention)

Trial Overview The study is testing a Target Navigation Pilot Program designed to support patients and their families by guiding them through the process of liver cancer diagnosis and treatment.

Participant Groups

Group I: Aim 3: Targeted Navigation Pilot Program Experimental Treatment 1 Intervention

Participants in this group will be enrolled in a Targeted Navigation Pilot Program for up to 12 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

The V Foundation

Collaborator

Trials

10

Recruited

320+

Findings from Research

Nurse navigation in cancer care has been associated with significant improvements in clinical outcomes, including reduced distress, anxiety, and depression among patients.

Patients receiving nurse navigation experienced better symptom management, improved physical conditioning, enhanced quality of life, and quicker initiation of treatment, highlighting the effectiveness of this approach in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. Rodrigues, RL., Schneider, F., Kalinke, LP., et al.[2022]

The navigation program for cancer patients showed marginally lower rates of emergency room visits and unplanned hospitalizations among those who used the service, indicating some potential benefits in care coordination.

However, the program had low visibility and utilization among patients, and overall patient experiences were mixed, suggesting that a more focused approach may be needed to effectively support high-risk or anxious patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. Winget, M., Holdsworth, L., Wang, S., et al.[2021]

The NDURE intervention, designed to improve timely postoperative radiation therapy (PORT) for head and neck squamous cell carcinoma (HNSCC), was found to be feasible and acceptable, with 100% of enrolled Black patients reporting positive experiences.

The implementation of NDURE resulted in an impressive 86% rate of timely, guideline-adherent PORT overall, and 100% for Black patients, highlighting its potential to address disparities in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of a Navigation-Based, Multilevel Intervention to Improve the Delivery of Timely, Guideline-Adherent Adjuvant Therapy for Patients With Head and Neck Cancer. Graboyes, EM., Sterba, KR., Li, H., et al.[2022]

Patient navigation interventions have shown some efficacy in increasing cancer screening participation by 10.8% to 17.1% and improving adherence to diagnostic follow-up care by 21% to 29.2% compared to control patients, based on a review of 16 studies.

However, there is limited evidence on the effectiveness of patient navigation in reducing late-stage cancer diagnoses or improving treatment initiation and survivorship outcomes, indicating a need for further research to assess their overall impact and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation: state of the art or is it science? Wells, KJ., Battaglia, TA., Dudley, DJ., et al.[2022]

The study evaluated a new technique for targeting hepatocellular carcinoma (HCC) using an intrahepatic electromagnetic reference, which showed a mean target positioning error of only 2.0 mm in a porcine liver model, indicating high precision.

The method demonstrated efficiency with an average navigated targeting time of 17.9 seconds, suggesting that this approach could streamline the ablation process for HCC in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A concept for electromagnetic navigated targeting of liver tumors using an angiographic approach. Schwalbe, M., Williamson, T., Paolucci, I., et al.[2018]

Stereotactic navigation techniques significantly improve targeting accuracy in thermal ablation of liver tumors, with a weighted average lateral targeting error of only 3.7 mm, compared to free-hand methods.

The primary technique efficacy of stereotactic navigation for tumor ablation is high, with 94% effectiveness within 1-6 weeks post-procedure, and 90% within 6-12 weeks, indicating that these methods enhance treatment outcomes while maintaining a low complication rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic and Robotic Minimally Invasive Thermal Ablation of Malignant Liver Tumors: A Systematic Review and Meta-Analysis. Tinguely, P., Paolucci, I., Ruiter, SJS., et al.[2022]

Microwave ablation using a real-time virtual navigation system was successfully performed on 18 patients with hepatocellular carcinoma (HCC) nodules that were undetectable by conventional ultrasound, achieving a high effectiveness rate of 94.44%.

The procedure was safe, with no severe complications reported and no local recurrences observed during a follow-up period of 3 to 12 months, indicating its feasibility as a treatment option for challenging cases of HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave ablation assisted by a real-time virtual navigation system for hepatocellular carcinoma undetectable by conventional ultrasonography. Liu, FY., Yu, XL., Liang, P., et al.[2016]

A study of 24 liver cancer patients showed that performing transarterial embolization followed by radiofrequency ablation in a single session using cone-beam CT and needle navigation software is both safe and effective, with similar complete response rates to traditional methods.

The single-session approach reduced the number of imaging scans needed (5.0 vs 8.5) and, despite longer procedure times, did not significantly increase radiation exposure, indicating a more efficient treatment option for larger tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Combined Transarterial Embolization and Percutaneous Radiofrequency Ablation for Liver Tumors Using Cone-Beam CT and Needle Navigation Software in a Single Session. Yamada, R., Bassaco, B., Dufour, L., et al.[2019]

A new formulation of carrier-free indocyanine green nanoparticles (nanoICG) was developed, which showed improved fluorescent properties and stability for accurately identifying liver cancer lesions during surgery.

In a clinical trial with a liver cancer patient, the nanoICG technology allowed for the detection of small tumors that traditional imaging missed, enabling complete tumor removal with less blood loss and a shorter surgery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical trial of super-stable homogeneous lipiodol-nanoICG formulation-guided precise fluorescent laparoscopic hepatocellular carcinoma resection. He, P., Xiong, Y., Ye, J., et al.[2022]

Laparoscopic image-guided microwave ablation (LIMA) for malignant liver tumors demonstrated a low complication rate of 24% for minor complications and only 4% for major complications, indicating a safe approach for patients.

The technique showed an early local recurrence rate of 9% per lesion and 32% per patient, with a significant portion of recurrences (63%) successfully re-ablated within 6 months, highlighting its efficacy in managing multiple liver lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic image-based navigation for microwave ablation of liver tumors-A multi-center study. Tinguely, P., Fusaglia, M., Freedman, J., et al.[2022]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Development and Evaluation of a Navigation-Based, Multilevel Intervention to Improve the Delivery of Timely, Guideline-Adherent Adjuvant Therapy for Patients With Head and Neck Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Patient navigation: state of the art or is it science? [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Patient navigation moderates emotion and information demands of cancer treatment: a qualitative analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A concept for electromagnetic navigated targeting of liver tumors using an angiographic approach. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic and Robotic Minimally Invasive Thermal Ablation of Malignant Liver Tumors: A Systematic Review and Meta-Analysis. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Microwave ablation assisted by a real-time virtual navigation system for hepatocellular carcinoma undetectable by conventional ultrasonography. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Combined Transarterial Embolization and Percutaneous Radiofrequency Ablation for Liver Tumors Using Cone-Beam CT and Needle Navigation Software in a Single Session. [2019]

10. Japan pubmed.ncbi.nlm.nih.gov

Outcomes of ultrasound-guided percutaneous argon-helium cryoablation of hepatocellular carcinoma. [2022]

11. England pubmed.ncbi.nlm.nih.gov

A clinical trial of super-stable homogeneous lipiodol-nanoICG formulation-guided precise fluorescent laparoscopic hepatocellular carcinoma resection. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Laparoscopic image-based navigation for microwave ablation of liver tumors-A multi-center study. [2022]