Liver Cancer (Primary and Metastatic)NCT07303725
Intra-procedural Spectral CT for Image-guided Embolization and Ablation in Interventional Oncology
An observational study of Liver Cancer (Primary and Metastatic) and Renal Cancer, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer (Primary and Metastatic), Renal Cancer
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with liver or kidney cancer being treated at VAPAHCS
Who may be able to join
- 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
Who cannot join
- Not eligible for indicated procedure.
- BMI > 35
- Prior surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Palo Alto Healthcare System
Palo Alto, California, 94304
Luisa Manfredi, MPH, 650-493-5000 ext. 61706, luisa.manfredi1@va.gov
Sirish Kishore, MD, 650-493-5000 ext. 68739, sirish.kishore@va.gov
About this study
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:
- 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.
- 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
- 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)
- During ablation with microwave, cryoablation, and irreversible electroporation in an ex vivo model
- For image-guided tumor ablation, such as lesion identification, probe placement, and ablation monitoring.
- Keywords
- spectral CT
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
CT image
Effective Dose and CTDI
Measured: Baseline
Secondary outcomes (2)
number
Number of spectral CT acquisitions per patient
Measured: Baseline
time
Fluoroscopy Time
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer (Primary and Metastatic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Responsible party
- Sponsor
- Investigators
- Sirish Kishore, MD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303725
- Sponsor's protocol ID
- KIS0004ARG
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-procedural Spectral CT for Image-guided Embolization and Ablation in Interventional Oncology
- ClinicalTrials.gov ID
- NCT07303725
- Acronym / sponsor ID
- KIS0004ARG
- Keywords
- spectral CT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
- 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
- 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)
- During ablation with microwave, cryoablation, and irreversible electroporation in an ex vivo model
- For image-guided tumor ablation, such as lesion identification, probe placement, and ablation monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with liver or kidney cancer being treated at VAPAHCS
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Not eligible for indicated procedure.
- BMI > 35
- Prior surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CT image
Time frame: Baseline
Effective Dose and CTDI
2 secondary outcomes
number
Time frame: Baseline
time
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sirish Kishore, MD principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer (Primary and Metastatic) and Renal Cancer, run by Palo Alto Veterans Institute for Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sirish Kishore, MD (650-493-5000 ext. 61706, sirish.kishore@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT image (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.