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Novel Gallium Imaging in Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
68Gallium Citrate
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring PET/CT, 68Gallium Citrate, Hepatocellular carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least one biopsy-confirmed or Liver Imaging Reporting and Data System (LI-RADS)- 5 HCC lesion, diagnosed within the past 6 weeks.
  • Lesion size greater than or equal to 3cm
  • At least one triple-phase CT or MRI of the liver prior to medical or surgical therapy

Exclusion Criteria:

  • Pregnant or breast-feeding women.
  • Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
  • Inability to consent
  • Prior medical or surgical therapy for HCC, including chemoembolization, radiofrequency ablation, and lobectomy
  • Known or suspected hypersensitivity to metals or gallium

Sites / Locations

  • Rutgers New Jersey Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug; 68Gallium Citrate

Arm Description

Procedure: PET/CT Imaging

Outcomes

Primary Outcome Measures

Uptake of positron emitting radiotracer, 68Gallium Citrate will be measured in the lesions of hepatocellular carcinoma.
For each subject, presence and location of abnormal radiotracer localization will be recorded. Tumor volume will be measured on CT, MRI, and PET/CT images using the MIM software. Region-of-interest (ROI) will be drawn around each area of morphologic abnormality on PET/CT images to calculate a mean standardized uptake value (SUV), a maximum SUV, and a target-to-background ratio.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2016
Last Updated
December 31, 2018
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Radiological Society of North America
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1. Study Identification

Unique Protocol Identification Number
NCT03116945
Brief Title
Novel Gallium Imaging in Hepatocellular Carcinoma
Official Title
68Gallium Citrate Imaging in Newly Diagnosed Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Radiological Society of North America

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the present study is to validate the uptake of novel, positron emitting radiotracer, 68Gallium Citrate in hepatocellular carcinoma(HCC). The investigators also aim to evaluate the sensitivity of 68Gallium (68Ga)-citrate positron emission tomography/computed tomography (PET/CT) for the identification of intrahepatic HCC lesions in comparison with existing modalities: computed tomography (CT) alone and magnetic resonance imaging (MRI). The investigators expect that 68Ga-citrate PET/CT will offer a sensitive functional imaging modality for identification of HCC lesions in the liver. The investigators intend to use the results of this preliminary study to fuel further studies in the utility of 68Ga-citrate PET/CT for HCC treatment monitoring.
Detailed Description
Hepatocellular carcinoma (HCC) is a malignancy of the liver with very high mortality. Management of HCC often involves interventional and surgical therapies that distort surrounding liver morphology. For this reason, current morphologic imaging techniques following these therapies often fail to distinguish between residual tumor and post-therapeutic morphologic changes. Therefore, there is the need for an effective imaging technique in therapy monitoring for HCC. Functional imaging techniques are commonly used in other cancers for effective therapy monitoring. Functional imaging in HCC with single photon emitting gallium radioisotopes has been explored in the past but have not been used routinely due to poor resolution of images. 68Gallium-citrate PET/CT can generate high resolution images that specifically target HCC cells regardless of liver morphology. This makes 68Gallium-citrate PET/CT an ideal imaging modality for HCC following therapies that distort liver morphology. Before determining its efficacy in therapy monitoring, The investigators aim to demonstrate the ability for 68Gallium-citrate PET/CT to localize known intrahepatic HCC lesions. In this pilot study, 18 subjects with newly diagnosed HCC will be recruited. Each subject will undergo a 68Gallium-citrate PET/CT scan within 6 weeks of radiographic diagnosis. Foci of abnormal radiotracer uptake on these scans will be tabulated and compared to clinically-indicated morphologic imaging. The investigators expect that 68Gallium-citrate PET/CT will offer a sensitive functional imaging modality for identification of HCC lesions in the liver. The investigators intend to use the results of this preliminary study to form the basis for grant applications to extra-mural funding agencies. These subsequent grant applications will focus on further studies in the utility of 68Gallium-citrate PET/CT for HCC therapy monitoring and metastatic work-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
PET/CT, 68Gallium Citrate, Hepatocellular carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug; 68Gallium Citrate
Arm Type
Experimental
Arm Description
Procedure: PET/CT Imaging
Intervention Type
Drug
Intervention Name(s)
68Gallium Citrate
Other Intervention Name(s)
Scintigraphy
Intervention Description
Procedure: PET/CT Imaging
Primary Outcome Measure Information:
Title
Uptake of positron emitting radiotracer, 68Gallium Citrate will be measured in the lesions of hepatocellular carcinoma.
Description
For each subject, presence and location of abnormal radiotracer localization will be recorded. Tumor volume will be measured on CT, MRI, and PET/CT images using the MIM software. Region-of-interest (ROI) will be drawn around each area of morphologic abnormality on PET/CT images to calculate a mean standardized uptake value (SUV), a maximum SUV, and a target-to-background ratio.
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least one biopsy-confirmed or Liver Imaging Reporting and Data System (LI-RADS)- 5 HCC lesion, diagnosed within the past 6 weeks. Lesion size greater than or equal to 3cm At least one triple-phase CT or MRI of the liver prior to medical or surgical therapy Exclusion Criteria: Pregnant or breast-feeding women. Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study. Inability to consent Prior medical or surgical therapy for HCC, including chemoembolization, radiofrequency ablation, and lobectomy Known or suspected hypersensitivity to metals or gallium
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasrin Ghesani, MD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
15508079
Citation
Gharib AM, Thomasson D, Li KC. Molecular imaging of hepatocellular carcinoma. Gastroenterology. 2004 Nov;127(5 Suppl 1):S153-8. doi: 10.1053/j.gastro.2004.09.029.
Results Reference
result

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Novel Gallium Imaging in Hepatocellular Carcinoma

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