PET/CT-Assessment of Liver Tumor Ablation

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Dana-Farber Cancer Institute
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Paul Shyn, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT02018107
First received: December 17, 2013
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

In this research study, the investigators are evaluating whether ammonia PET scans are more useful in helping radiologists determine whether liver tumors were successfully destroyed by the heating or freezing procedures (ablations) than other scans currently available to radiologists, such as CT scans and MRI scans.

The currently available scan (usually a CT scan with contrast dye) is not always effective in showing how completely the tumor has been destroyed. The ammonia PET scan is a different way of looking at how much tumor has been destroyed. This study will compare the standard scan (CT scan) with the ammonia PET scan.


Condition Intervention
Liver Tumor
Liver Neoplasms
Radiation: N-13 ammonia
Device: PET/CT scanner

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PET/CT-Guided Liver Tumor Ablation: Intraprocedural Assessment of Results Using Ammonia Perfusion PET

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Number and percentage of tumors with complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations (AP-PET-1 v. CECT) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    For FDG-avid tumors, compare the rates of complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations using two imaging techniques: intra-procedural AP-PET-1(research scan #1) and intra-procedural CECT. Discordance rates for complete ablation margin visibility between the two imaging techniques will be calculated.

  • Number and percentage of tumors with complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations (AP-PET-1 v. PET/CECT) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    For FDG-avid tumors, compare the rates of complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations using two imaging techniques: intra-procedural AP-PET-1 alone and intra-procedural CECT fused with FDG PET (FDG PET/CECT). Discordance rates for complete ablation margin visibility between the two imaging techniques will be calculated.

  • Ablation Margin Assessment: Percentage Adequate or Not Adequate [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    In assessing adequacy of the ablation margin for FDG-avid tumors, the concordance rates of final intra-procedural AP-PET(research scan #1 or #2) with gold standard 24-hour post-procedure MRI or CT will be determined. (Includes patients with renal insufficiency who cannot receive intra-procedural iodinated IV contrast.)

  • Non-FDG-Avid Tumors- Percentage of tumors with complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    For non-FDG-avid tumors, compare the rates of complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations using two imaging techniques: 1) intra-procedural AP-PET-1 fused to pre-procedural MRI or CT and 2) intra-procedural CECT fused to pre-procedural MRI or CT. Discordance rates for complete ablation margin visibility between the two imaging techniques will be calculated.

  • Ablation margin assessment of non-FDG-avid tumors: concordance rate of AP-PET fused to pre-procedural MRI v. 24-hour post-procedure MRI or CT [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    In assessing adequacy of the ablation margin for non-FDG-avid tumors, the concordance rate of final intra-procedural AP-PET (research scan #1 or #2) fused to pre-procedural MRI or CT with gold standard 24-hour post-procedure MRI or CT will be determined. (Includes patients with renal insufficiency who cannot receive intra-procedural iodinated IV contrast


Secondary Outcome Measures:
  • FDG-Tumor-Tumor Rate Progression [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    For FDG-avid tumors, rates of local tumor progression based on a minimum of 3-12 month imaging follow-up will be compared for ablation margin adequacy assessed by blinded retrospective reads of final intraprocedural AP-PET (research scan #1 or #2) and 24-hour post-procedure MRI or CT. (Includes patients with renal insufficiency who cannot receive intra-procedural iodinated IV contrast.)


Estimated Enrollment: 75
Study Start Date: January 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N-13 ammonia to image liver perfusion with a PET scanner
This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only
Radiation: N-13 ammonia Device: PET/CT scanner
Other Name: Siemens mCT

Detailed Description:

The plan for this study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The patient will receive one or two doses of N-13 ammonia (10 mCi (millicurie)/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only. The ammonia perfusion scan will not be used to change or modify the ablation procedure.

After the screening procedures confirm that that the participant is eligible to participate in the research study:

  • Ammonia Perfusion PET: The participant will be scheduled for the tumor ablation procedure as part of the participant's routine care. If the participant decided to take part in this research study, then the participant will have one or two ammonia perfusion PET scans during the ablation procedure to see if the ablation was successful or not as compared to standard CT scanning. The ammonia perfusion PET scans are the research part of the participant's procedure. The rest of the participant's procedure is not research. The participant will receive one or two doses of the radioactive tracer called N-13 ammonia. This tracer is administered through the same IV (thin tube placed in a vein) used by the Anesthesiologist to give the participant routine medications that relax the participant, prevent pain, and allow the participant to sleep during the procedure. This tracer does not treat the participant's tumor in any way. Instead, the tracer may allow the radiologist to better see how much of the participant's tumor was destroyed.
  • Photographs: Photographs may be taken during the procedure. Care will be taken to ensure these do not reveal the participant's identity.
  • Clinic visits: The investigators routinely see patients after tumor ablation procedures within one to two weeks after the procedure and then every three months after the procedure for one to two years, and as needed in the future. Accordingly, the clinic visits are routine and not an added research commitment.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults, 18 years or older
  • Referral from an internist, oncologist, or surgeon for liver tumor ablation consultation
  • ECOG (Eastern Cooperative Oncology Group) Performance Status < 3
  • Liver tumor ablation judged to be appropriate based on clinical assessment in the BWH (Brigham & Women's Hospital) Tumor Ablation Clinic by the tumor ablation interventional radiologist, per standard clinical practice
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Uncorrectable coagulopathy (due to bleeding risk)
  • Pulmonary disease precluding monitored anesthesia care or general anesthesia
  • Severe renal insufficiency, EGFR (estimated glomerular filtration rate) < 30
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Childs-Pugh Class C cirrhosis
  • Occlusive main portal vein thrombosis
  • Presence of biliary-enteric anastomosis (due to risk of biliary infection)
  • Pregnant women are excluded (because both CT and PET/CT scans involve the use of ionizing radiation which may pose a potential teratogenic effect on the fetus.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018107

Contacts
Contact: Paul B. Shyn, M.D. (617) 732-8353 pshyn@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Paul B Shyn, MD    617-732-8353    pshyn@partners.org   
Principal Investigator: Paul B Shyn, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Paul B Shyn, MD    617-732-8353    pshyn@partners.org   
Principal Investigator: Paul B Shyn, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Paul B. Shyn, M.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Paul Shyn, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02018107     History of Changes
Other Study ID Numbers: 13-464
Study First Received: December 17, 2013
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Liver Tumor Ablation
Liver Neoplasms
Positron Emission Tomography
Computed Tomography

Additional relevant MeSH terms:
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 30, 2014