Novel Gallium Imaging in Hepatocellular Carcinoma

NCT03116945 | Unknown Phase 2

• 1 other identifier: 20150001631
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

PET/CT; 68Gallium Citrate; Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  One Year

Study Arms (1)

Drug; 68Gallium Citrate

EXPERIMENTAL

Procedure: PET/CT Imaging

Drug: 68Gallium Citrate

Interventions

68Gallium Citrate DRUG

Procedure: PET/CT Imaging

Also known as: Scintigraphy

Drug; 68Gallium Citrate

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Radiological Society of North America: collaborator

Study Sites (1)

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Related Publications (1)

• 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.

  PMID: 15508079 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Nasrin Ghesani, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: April 17, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 3, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)