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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Liver Tumor
Liver Neoplasms
Interventions Diagnostic Test: N-13 ammonia or F-18 fluorodeoxyglucose
Diagnostic Test: PET scan
Enrollment 33
Recruitment Details

33 unique participants were enrolled and consented for this study, 6 participants were then excluded from the study.

Thus, the count of subjects is 27 who were assigned to intervention. Out of 27 participants, 1 subject participated in both interventions.

Pre-assignment Details

33 unique participants were enrolled and consented for this study, 6 participants were then excluded from the study.

Thus, the count of subjects is 27. Out of 27 participants, 1 subject participated in both interventions.

Arm/Group Title N-13 Ammonia to Image Liver PET Perfusion
Hide Arm/Group Description

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

N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer

PET scan: PET scan

Period Title: Overall Study
Started 27
Completed 27
Not Completed 0
Arm/Group Title N-13 Ammoniaor F-18 Fluorodeoxygl to Image Liver PET Perfusion
Hide Arm/Group Description

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

N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer

PET scan: PET scan

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
There were 27 unique participants and one participant participated twice (in both interventions).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  51.9%
>=65 years
13
  48.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
13
  48.1%
Male
14
  51.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
In this study, the number of tumors were analysed. There 8 participants with 11 tumors that were analysed for N-13 ammonia to image liver PET perfusion and 31 tumors in 20 patients were analysed in F-18 fluorodeoxyglucose to image liver PET perfusion. 1 participant participated in both interventions. Total unique participants 27.
Arm/Group Title N-13 Ammonia or F-18 to Image Liver PET Perfusion
Hide Arm/Group Description:

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

N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer

PET scan: PET scan

Overall Number of Participants Analyzed 27
Overall Number of Units Analyzed
Type of Units Analyzed: Tumors
42
Count of Units
Unit of Measure: Tumors
Total Tumors
42
 100.0%
Assessibility of ablation margin by Pet Perfusion
40
  95.2%
Assessibility of ablation margin by MRI
25
  59.5%
2.Secondary Outcome
Title Does an Inadequate Ablation Margin on PET Predict Local Progression? Compare to MRI?
Hide Description Percentage of tumors with an inadequate margin on PET that progressed locally? Compare to MRI?
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-13 Ammonia or F-18 to Image Liver PET Perfusion
Hide Arm/Group Description:

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

N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer

PET scan: PET scan

Overall Number of Participants Analyzed 27
Overall Number of Units Analyzed
Type of Units Analyzed: Tumors
42
Measure Type: Number
Unit of Measure: percentage of tumors
PET:% local progression based on inadequate margin 53.84
MRI:% local progression based on Inadequate margin 83.33
PET: % local non-progression per adequate margin 96.29
MRI: % local non-progression per adequate margin 89.47
Time Frame 3 months
Adverse Event Reporting Description 27 participants were at risk
 
Arm/Group Title N-13 Ammonia to Image Liver PET Perfusion
Hide Arm/Group Description

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

N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer

PET scan: PET scan

All-Cause Mortality
N-13 Ammonia to Image Liver PET Perfusion
Affected / at Risk (%)
Total   0/27 (0.00%) 
Hide Serious Adverse Events
N-13 Ammonia to Image Liver PET Perfusion
Affected / at Risk (%)
Total   0/27 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N-13 Ammonia to Image Liver PET Perfusion
Affected / at Risk (%)
Total   0/27 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul Shyn, MD
Organization: Brigham & Women's Hospital INC
Phone: 6177326304
EMail: PSHYN@BWH.HARVARD.EDU
Layout table for additonal information
Responsible Party: Paul Shyn, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02018107    
Other Study ID Numbers: 13-464
First Submitted: December 17, 2013
First Posted: December 23, 2013
Results First Submitted: January 13, 2020
Results First Posted: March 26, 2020
Last Update Posted: March 26, 2020