Novel Gallium Imaging in Hepatocellular Carcinoma



Status:Active, not recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:June 2016
End Date:December 2020

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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.

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.

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
We found this trial at
1
site
Newark, New Jersey 07103
Principal Investigator: Nasrin Ghesani, MD
Phone: 973-972-1770
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mi
from
Newark, NJ
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