Clinical Trial on Renal Cancer, Liver Cancer (Primary and Metastatic) - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Detailed Description

The aims of this study are:

Demonstrate the feasibility of acquisition and image quality of intra-arterial spectral CT images obtained during mapping arteriography prior to trans arterial radioembolization (TARE) for liver cancer treatment.
1. Assess the procedural utility of Spectral CT images as part of the TARE workflow, such as hepatopulmonary shunt fraction estimation, lesion identification, prediction of tumor: normal liver (T:N) dose ratio, and dose distribution
2. Investigate the feasibility, safety, and image quality of Spectral CT images obtained during tumor ablation.
Explore the feasibility of assessing physiologic tissue changes using Spectral CT (effective anatomic number maps)
1. During ablation with microwave, cryoablation, and irreversible electroporation in an ex vivo model
2. For image-guided tumor ablation, such as lesion identification, probe placement, and ablation monitoring.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sirish Kishore, MD
Phone Number: 61706 650-493-5000
Email: sirish.kishore@va.gov

Study Contact Backup

Name: Luisa Manfredi, MPH
Phone Number: 61706 650-493-5000
Email: luisa.manfredi1@va.gov

Study Locations

United States
- California
  - Palo Alto, California, United States, 94304
    - Recruiting
    - VA Palo Alto Healthcare System
    - Principal Investigator:
      
      Sirish Kishore, MD
    - Contact:
      
      Luisa Manfredi, MPH
      
      Phone Number: 61706 650-493-5000
      
      Email: luisa.manfredi1@va.gov
    - Contact:
      
      Sirish Kishore, MD
      
      Phone Number: 68739 650-493-5000
      
      Email: sirish.kishore@va.gov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with liver or kidney cancer being treated at VAPAHCS

Description

Inclusion criteria:

Age > or = 18 years
Tumor in an area without prior surgical or ablative therapy
At least 1 tumor greater than 1.5 cm in greatest diameter

Exclusion criteria:

Not eligible for indicated procedure.
BMI > 35
Prior surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
angiography mapping Hepatocellular carcinoma (HCC) patients undergoing hepatic angiography mapping prior to TARE (N=10)
microwave ablation percutaneous tumor ablation in patients receiving image-guided tumor ablation using MWA (n=10)
cryoablation cryoablation (N=10) for primary liver (HCC) or primary kidney tumors (RCC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT image Time Frame: Baseline	Effective Dose and CTDI	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number Time Frame: Baseline	Number of spectral CT acquisitions per patient	Baseline
time Time Frame: Baseline	Fluoroscopy Time	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Veterans Institute for Research

Collaborators

Canon Medical Systems, USA

Investigators

Principal Investigator: Sirish Kishore, MD, VA Palo Alto Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)