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Software-Aided Imaging (Morfeus) for Confirming Tumor Coverage With Ablation in Patients With Liver Tumors, the COVER-ALL Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083378
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase II trial studies how well software-aided imaging works in confirming tumor coverage with ablation (the removal or destruction of a body part or tissue or its function) on patients with liver tumors. The current standard for targeting tumor cells and evaluating the outcome of a liver ablation procedure is a visual inspection of the pre- and post-procedure computed tomography (CT) scans. Software-aided imaging systems, such as Morfeus, may help to improve the accuracy and effectiveness of liver ablation.

Condition or disease Intervention/treatment Phase
Malignant Liver Neoplasm Procedure: Ablation Therapy Procedure: Image-Guided Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. To evaluate if the intra-procedure feedback of a biomechanical deformable registration volumetric image method during percutaneous ablation will increase the minimal ablation margins on a three-dimensional computed tomography-generated analysis.

SECONDARY OBJECTIVES:

I. To assess whether applying the proposed method during percutaneous ablation improves local tumor progression-free survival (LTPFS) rates.

II. Evaluate impact of software use on procedure workflow. III. Impact of software use on complication rates, quality of life, liver function.

IV. Evaluate oncological outcomes (intra-hepatic and overall progression-free survivals, and overall survival).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo standard of care ablation.

ARM II: Patients undergo standard of care ablation with software-aided imaging (Morfeus).

After completion of study, patients are followed up at 1, 3, and 6 months, and then at 1 and 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Impact of a Volumetric Image Method for Confirming Tumor Coverage With Ablation on Patients With Malignant Liver Lesions (COVER-ALL)
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm I (standard of care ablation)
Patients undergo standard of care ablation.
Procedure: Ablation Therapy
Undergo standard of care ablation
Other Names:
  • ABLATION
  • Catheter Ablation
  • Local Ablation Therapy
  • Local Ablative Therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm II (standard of care ablation, software-aided imaging)
Patients undergo standard of care ablation with software-aided imaging (Morfeus).
Procedure: Ablation Therapy
Undergo standard of care ablation
Other Names:
  • ABLATION
  • Catheter Ablation
  • Local Ablation Therapy
  • Local Ablative Therapy

Procedure: Image-Guided Therapy
Undergo software-aided imaging (Morfeus)
Other Names:
  • Image Guided Therapy
  • Imaging Guided Therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Impact of software use on the minimal margins of ablated lesions properly covered by ablation on a three-dimensional analysis [ Time Frame: Up to 2 years ]
    Will assess whether applying biomechanical models increase the minimal margins of ablated lesions properly covered by ablation on a three-dimensional analysis. The average minimum ablation margins will be compared between two arms using a 2-sample t-test (or Wilcoxon rank-sum test). The means and corresponding 95% confidence intervals will be reported for both arms of the study.


Secondary Outcome Measures :
  1. Local tumor progression-free survival (LTPFS) [ Time Frame: From date of ablation to earliest date of progression at the ablated lesion, assessed up to 2 years ]
    Kaplan-Meier method will be used to estimate LTPFS and 95% confidence intervals for the quantiles of the LTPFS function based on the method of Brookmeyer and Crowley will be calculated for each arm.

  2. Intra-hepatic progression-free survival [ Time Frame: From date of ablation to earliest date of progression at the ablated lesion, assessed up to 2 years ]
    Kaplan-Meier method will be used to estimate intra-hepatic progression-free survival and 95% confidence intervals for the quantiles of the intra-hepatic progression-free survival function based on the method of Brookmeyer and Crowley will be calculated for each arm.

  3. Overall survival [ Time Frame: From date of ablation to death, assessed up to 2 years ]
    Kaplan-Meier method will be used to estimate overall survival and 95% confidence intervals for the quantiles of the overall survival function based on the method of Brookmeyer and Crowley will be calculated for each arm.

  4. Complication rates [ Time Frame: Up to 2 years ]
    Standard summary statistics will be computed for complication rates and compared between arms.

  5. Quality of life [ Time Frame: Up to 2 years ]
    Standard summary statistics will be computed for quality of life and compared between arms.

  6. Liver function [ Time Frame: Up to 2 years ]
    Standard summary statistics will be computed for liver function and compared between arms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with =< 3 liver tumors (biopsy-proven or documented by imaging) measuring 1 to 3 cm planned to undergo percutaneous thermal ablation with either microwave or radiofrequency ablation
  • Ability to completely cover the target lesion as determined by routine pre-procedure imaging (CT or magnetic resonance [MR])
  • Written informed consent to voluntarily participate in the study and follow-up CT scan schedule
  • Performance status 0-2 (Eastern Cooperative Oncology Group Classification [ECOG])
  • Target tumor should be visualized on contrast-enhanced CT
  • Adequate glomerular filtration rate

Exclusion Criteria:

  • Active bacterial infection or fungal infection on the day of the ablation
  • Patients with implantable pacemakers or other electronic implants
  • Platelet < 50,000/mm^3
  • International normalized ratio (INR) > 1.5
  • Patients with uncorrectable coagulopathy
  • Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test)
  • Physical or psychological condition which would impair study participation
  • ASA (American Society of Anesthesiologists) score of >= 4
  • Any other loco-regional therapies at the target lesion(s) within 30 days of the ablation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083378


Contacts
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Contact: BRUNO C. ODISIO 713-563-1066 bcodisio@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: BRUNO C. ODISIO    713-563-1066      
Principal Investigator: BRUNO C. ODISIO         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: BRUNO C ODISIO M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04083378    
Other Study ID Numbers: 2019-0213
NCI-2019-05762 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-0213 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases