PET/CT-Assessment of Liver Tumor Ablation

March 4, 2020 updated by: Paul Shyn, MD, Dana-Farber Cancer Institute

PET/CT-Guided Liver Tumor Ablation: Intraprocedural Assessment of Results Using Ammonia Perfusion PET

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Diagnostic test: PET scan
PET scan
Diagnostic test: N-13 ammonia or F-18 fluorodeoxyglucose
PET tracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Paul B. Shyn, M.D., Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

February 16, 2018

Study Completion (ACTUAL)

February 16, 2019

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (ESTIMATE)

December 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-464

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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