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RecruitingNCT07303725Updated Dec 26, 2025

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

An observational study in Liver Cancer (Primary and Metastatic) and Renal Cancer, sponsored by Palo Alto Veterans Institute for Research. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by Palo Alto Veterans Institute for Research · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed 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.
02

Conditions studied

  • Liver Cancer (Primary and Metastatic)
  • Renal Cancer

Keywords

  • spectral CT
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with liver or kidney cancer being treated at VAPAHCS

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

Exclusion criteria:

  1. Not eligible for indicated procedure.
  2. BMI > 35
  3. Prior surgery.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

05

What researchers measure

Primary outcomes

  1. CT image

    Effective Dose and CTDI

    Time frame: Baseline

Secondary outcomes

  1. number

    Number of spectral CT acquisitions per patient

    Time frame: Baseline

  2. time

    Fluoroscopy Time

    Time frame: Baseline

06

Study locations

1 of 1 sites recruiting
  • VA Palo Alto Healthcare System
    Palo Alto, California 94304, United States
    Recruiting
07

References and documents

Study documents

  • Informed consent form · Aug 27, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07303725
Lead sponsor
Palo Alto Veterans Institute for Research
Collaborators
Canon Medical Systems, USA
Responsible party
Sponsor
First posted
Dec 26, 2025
Start date
Feb 1, 2025
Primary completion
Feb 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Dec 26, 2025

Study contacts

Sirish Kishore, MD
Contact
sirish.kishore@va.gov
650-493-5000 ext. 61706
Luisa Manfredi, MPH
Contact
luisa.manfredi1@va.gov
650-493-5000 ext. 61706
Sirish Kishore, MD
principal investigator · VA Palo Alto Health Care System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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