PET/CT-Assessment of Liver Tumor Ablation

NCT02018107 | Completed Results DMC FDA Drug

• 1 other identifier: 13-464
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Liver Tumor; Liver Neoplasms

Keywords

Liver Tumor Ablation; Liver Neoplasms; Positron Emission Tomography; Computed Tomography

Outcome Measures

Primary Outcomes (1)

• 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)

  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 Outcomes (1)

• Does an Inadequate Ablation Margin on PET Predict Local Progression? Compare to MRI?

  2 Years

Study Arms (1)

N-13 ammonia to image liver PET perfusion

EXPERIMENTAL

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: N-13 ammonia or F-18 fluorodeoxyglucose; Diagnostic Test: PET scan

Interventions

N-13 ammonia or F-18 fluorodeoxyglucose DIAGNOSTIC_TEST

PET tracer

N-13 ammonia to image liver PET perfusion

PET scan DIAGNOSTIC_TEST

PET scan

N-13 ammonia to image liver PET perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Shyn PB, Cubre AJ, Catalano PJ, Lee LK, Hyun H, Tuncali K, Seol JG, Levesque VM, Gerbaudo VH, Kapur T, Chao RT, Silverman SG. F-18 FDG perfusion PET: intraprocedural assessment of the liver tumor ablation margin. Abdom Radiol (NY). 2021 Jul;46(7):3437-3447. doi: 10.1007/s00261-021-02970-8. Epub 2021 Feb 19.

  PMID: 33606061 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: Paul Shyn, MD
• Organization: Brigham & Women's Hospital INC

PSHYN@BWH.HARVARD.EDU

6177326304

Study Officials

• Paul B. Shyn, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: January 1, 2014
• Primary Completion: February 16, 2018
• Study Completion: February 16, 2019
• Last Updated: March 26, 2020
• Results First Posted: March 26, 2020

Record last verified: 2020-03

Locations

US (2)