Intra-procedural Spectral CT for Image-guided Embolization and Ablation in Interventional Oncology

Palo Alto Veterans Institute for Research

Status: Enrolling

Conditions: Liver Cancer (Primary and Metastatic); Renal Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07303725

KIS0004ARG

Details and patient eligibility

About

This is a pilot study to evaluate the feasibility, image quality, and procedural utility of a novel spectral CT technique using Canon Medical's 4D CT system during image-guided interventional oncology procedures

Full description

The aims of this study are:

1. 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.

2. 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Not eligible for indicated procedure.
2. BMI > 35
3. Prior surgery.

Trial design

30 participants in 3 patient groups

angiography mapping

Description:

Hepatocellular carcinoma (HCC) patients undergoing hepatic angiography mapping prior to TARE (N=10)

microwave ablation

Description:

percutaneous tumor ablation in patients receiving image-guided tumor ablation using MWA (n=10)

cryoablation

Description:

cryoablation (N=10) for primary liver (HCC) or primary kidney tumors (RCC)