Novel Gallium Imaging in Hepatocellular Carcinoma

December 31, 2018 updated by: Nasrin Ghesani, Rutgers, The State University of New Jersey

68Gallium Citrate Imaging in Newly Diagnosed Hepatocellular Carcinoma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Drug; 68Gallium Citrate
Procedure: PET/CT Imaging
Drug: 68Gallium Citrate
Procedure: PET/CT Imaging
Other Names:
  • Scintigraphy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Uptake of positron emitting radiotracer, 68Gallium Citrate will be measured in the lesions of hepatocellular carcinoma.
Time Frame: One Year
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.
One Year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Radiological Society of North America

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 (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20150001631

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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