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

NCT ID: NCT07303725

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-09-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Liver Cancer (Primary and Metastatic) Renal Cancer

Keywords

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spectral CT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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angiography mapping

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

No interventions assigned to this group

microwave ablation

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

No interventions assigned to this group

cryoablation

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canon Medical Systems, USA

INDUSTRY

Sponsor Role collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sirish Kishore, MD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System

Locations

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VA Palo Alto Healthcare System

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sirish Kishore, MD

Role: CONTACT

Phone: 650-493-5000

Email: [email protected]

Luisa Manfredi, MPH

Role: CONTACT

Phone: 650-493-5000

Email: [email protected]

Facility Contacts

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Luisa Manfredi, MPH

Role: primary

Sirish Kishore, MD

Role: backup

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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KIS0004ARG

Identifier Type: -

Identifier Source: org_study_id