Targeted Navigation for Liver Cancer

Overseen By Gloria Figueroa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

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

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to better support people with liver cancer by understanding their personal experiences and needs. The goal is to create a program that assists patients and their families in navigating the diagnosis and treatment process. Participants will join a special pilot program, the Target Navigation Pilot Program, for up to 12 months. Suitable candidates include individuals diagnosed with liver cancer (hepatocellular carcinoma) and those who have supported someone with this condition. As an unphased trial, this study provides a unique opportunity to contribute to developing supportive care strategies for liver cancer patients.

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 prior data suggests that this Target Navigation Pilot Program is safe for patients with liver cancer?

Research has shown that the Target Navigation Pilot Program, designed to assist liver cancer patients, is currently being tested for safety and effectiveness. Studies are examining how well patients manage the program. Although specific safety data is not yet available, the program is not a drug or surgery, so it typically presents fewer safety concerns. The program aims to guide patients through their treatment, generally involving minimal risk. Participants can expect an improved treatment experience with little to no risk of harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Targeted Navigation Pilot Program for liver cancer because it offers a more personalized approach to treatment. Unlike traditional methods like surgery, chemotherapy, or radiofrequency ablation, which can be invasive and have significant side effects, this program focuses on guiding treatment with precision. By using advanced navigation techniques, it aims to target cancerous tissues more accurately, potentially reducing damage to healthy liver tissue and improving patient outcomes. This innovative approach could lead to more effective and safer treatment options for liver cancer patients.

What evidence suggests that the Target Navigation Pilot Program is effective for liver cancer patients?

Research has shown that patient navigation programs can help coordinate care for people with liver cancer. One study found that these programs guide patients through treatment, making the process easier and less stressful. In a pilot program for cancer patients, 67% completed the program, and 75% finished their treatment. These results suggest that navigation programs can help patients complete their treatment more effectively. Participants in this trial will enroll in the Targeted Navigation Pilot Program. While specific data on this program is limited, these findings support its potential to benefit liver cancer patients. ^{3 4 6 7 8}

Who Is on the Research Team?

Patricia Jones, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Target Navigation Pilot Program

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.

How Is the Trial Designed?

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+

The V Foundation

Collaborator

Trials

10

Recruited

320+

Published Research Related to This Trial

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]

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]

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]

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]

In a study of 300 patients with hepatocellular carcinoma (HCC), ultrasound-guided percutaneous cryoablation showed effectiveness, with 185 tumors completely ablated, particularly for smaller tumors (mean diameter 5.6 cm) compared to incompletely ablated tumors (mean diameter 7.2 cm).

The procedure had a relatively low complication rate (6.3%), but serious complications did occur, including cryoshock syndrome and liver failure, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of ultrasound-guided percutaneous argon-helium cryoablation of hepatocellular carcinoma. Yang, Y., Wang, C., Lu, Y., 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]

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]

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]

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]

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 significantly enhances patients' involvement in their cancer treatment, particularly by addressing emotional and informational needs, as highlighted in interviews with 28 cancer patients.

The study emphasizes the importance of a strong partnership between patients and navigators, suggesting that emotional support and effective communication are more critical than logistical assistance in the navigation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation moderates emotion and information demands of cancer treatment: a qualitative analysis. Rousseau, SJ., Humiston, SG., Yosha, A., et al.[2021]

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/461295

Targeted Navigation in Hepatocellular Carcinoma (HCC) The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11460540/

A pilot navigation program for Asian American cancer ... Forty-two percent of participants had lung, 38% colorectal, and 21% liver cancer. Of 24 participants who enrolled, 67% completed the program and 75% completed ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11847208/

Robotic navigation-assisted percutaneous liver puncture This study aimed to assess the safety and efficacy of RNAP in the treatment of liver tumors.

4. withpower.com withpower.com/trial/phase-carcinoma-hepatocellular-4-2024-9813b

Targeted Navigation for Liver Cancer Research shows that patient navigation programs, which help guide patients through cancer treatment, have been effective in improving care coordination and ...

5. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-025-01448-1

protocol for a large cluster-randomized implementation study Comparing the effectiveness of implementation strategies to improve liver and colon cancer screening for Veterans: protocol for a large cluster ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06260943

Targeted Navigation in Hepatocellular Carcinoma (HCC) It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

7. targetrwe.com targetrwe.com/unique-data/registries/target-hcc/

TARGET-HCC TARGET-HCC is a 5-year longitudinal, observational study sponsored by Target RWE which captures data of patients with hepatocellular carcinoma.

8. ascopubs.org ascopubs.org/doi/10.1200/OP.2024.20.10_suppl.263

A qualitative study identifying the navigation needs of ... We aimed to ascertain the needs of HCC patients, and identify obstacles limiting access to cancer treatment and supports needed for successful HCC treatment.