Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

PET/CT-Assessment of Liver Tumor Ablation

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02018107
Recruitment Status : Completed
First Posted : December 23, 2013
Results First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Paul Shyn, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE December 17, 2013
First Posted Date  ICMJE December 23, 2013
Results First Submitted Date  ICMJE January 13, 2020
Results First Posted Date  ICMJE March 26, 2020
Last Update Posted Date March 26, 2020
Study Start Date  ICMJE January 2014
Actual Primary Completion Date February 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2020)
Number and Percentage of Tumors With Complete, Circumferential Ablation Margin Visibility During FDG PET/CT-guided Liver Ablations (AP-PET-1 v. Contrast-enhanced MRI) [ Time Frame: 2 Years ]
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 post-procedural contrast enhanced MRI . Discordance rates for complete ablation margin visibility between the two imaging techniques will be calculated.
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2020)
Does an Inadequate Ablation Margin on PET Predict Local Progression? Compare to MRI? [ Time Frame: 2 Years ]
Percentage of tumors with an inadequate margin on PET that progressed locally? Compare to MRI?
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
FDG-Tumor-Tumor Rate Progression [ Time Frame: 2 Years ]
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.)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PET/CT-Assessment of Liver Tumor Ablation
Official Title  ICMJE PET/CT-Guided Liver Tumor Ablation: Intraprocedural Assessment of Results Using Ammonia Perfusion PET
Brief Summary

In this research study, the investigators are evaluating whether ammonia PET scans or FDG PET perfusion 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.

Detailed Description

The plan for this study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The 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 or F-18 fluorodeoxyglucose 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a diagnostic imaging study, involving FDA-approved radiopharmaceuticals. Applying a "Phase" to the study is N/A, even though the Study Phase had to be entered above.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Liver Tumor
  • Liver Neoplasms
Intervention  ICMJE
  • Diagnostic Test: N-13 ammonia or F-18 fluorodeoxyglucose
    PET tracer
  • Diagnostic Test: PET scan
    PET scan
Study Arms  ICMJE Experimental: N-13 ammonia to image liver PET perfusion
This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, 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
Interventions:
  • Diagnostic Test: N-13 ammonia or F-18 fluorodeoxyglucose
  • Diagnostic Test: PET scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2020)
33
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2013)
75
Actual Study Completion Date  ICMJE February 16, 2019
Actual Primary Completion Date February 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02018107
Other Study ID Numbers  ICMJE 13-464
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Shyn, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Brigham and Women's Hospital
Investigators  ICMJE
Principal Investigator: Paul B. Shyn, M.D. Brigham and Women's Hospital
PRS Account Dana-Farber Cancer Institute
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP