RECRUITING

Stereotactic Liver Ablation Assisted with Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To achieve adequate tumor treatment coverage with sufficient minimal ablation margins, several steps are required: firstly, it is critical to define tumor boundaries and extent on intra-procedural CT image; secondly, accurate planning, targeting, and confirmation of ablation probe placement within the tumor; thirdly, the use of an intra-procedural imaging assessment method to evaluate minimal ablation margins is required to define whether sufficient minimal ablation margins was obtained or if additional ablation is needed. Taking all together, those factors points to the need of having a high-precision ablation methodology for intra-procedural planning, monitoring, and ablation margin assessment. Currently, such methods are only utilized in isolation and the benefit of a combined and standardized procedure workflow is unknown. Therefore, our primary goal of this single-arm clinical trial is to investigate the technical efficacy of a high-precision liver ablation technique comprised by stereotactic-guidance, CT during hepatic arteriography-based imaging analysis, and computer-based software assessment of ablation margins for the treatment of patients referred to ablation for the treatment of primary and secondary liver cancers.

Official Title

Stereotactic Liver Ablation Assisted with Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)

Quick Facts

Study Start:2023-02-21
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05361551

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients presenting with up to 5 colorectal liver metastasis measuring up to 5 cm who are referred to percutaneous ablation;
  2. 2. Ability to completely cover the target tumor with at least a 5 mm ablation margin as determined per pre-procedure cross-sectional imaging;
  3. 3. Distance to central bile ducts \> 1 cm;
  4. 4. Adequate glomerular filtration rate (GFR \> 40) and no severe allergies to iodine contrast-media;
  5. 5. Ability to understand and the willingness to sign written informed consent;
  6. 6. Age \> 18 years-old;
  7. 7. Performance status 0-2 (Eastern Cooperative Oncology Group Classification \[ECOG\]);
  8. 8. Expected survival \> 12 months.
  1. 1. Use of other prior or concomitant local therapy at the target tumor(s).
  2. 2. Active bacterial infection or fungal infection on the day of the ablation.
  3. 3. Platelet \< 50,000/mm3.
  4. 4. INR \> 1.5
  5. 5. Patients with uncorrectable coagulopathy.
  6. 6. Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
  7. 7. Physical or psychological condition which would impair study participation.
  8. 8. ASA (American Society of Anesthesiologists) score of ≥ 4.
  9. 9. Any other loco-regional therapies at the target lesion(s).
  10. 10. Anatomical variations in the arterial-hepatic blood supply of the liver that preclude the use of CTHA imaging.

Contacts and Locations

Study Contact

Bruno Odisio, MD
CONTACT
(713) 563-1066
bcodisio@mdanderson.org

Principal Investigator

Bruno Odisio, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Bruno Odisio, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Registration Dates

Study Start Date2023-02-21
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2023-02-21
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Liver Ablation
  • Hepatic