PET-CT in Determining the Radioembolization Dose Delivered to Patients With Liver Metastasis, Primary Liver Cancer, or Biliary Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Fox Chase Cancer Center
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT02088775
First received: March 13, 2014
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

This clinical trial studies positron emission tomography (PET)-computed tomography (CT) in determining the radiation dose delivered with radioactive spheres to patients with liver metastasis or primary liver or biliary cancer. Comparing results of diagnostic procedures dose before and after delivery of radioactive spheres to the liver may help determine radioembolization dose and plan the best treatment for liver metastasis or primary liver or biliary cancer.


Condition Intervention
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Metastatic Extrahepatic Bile Duct Cancer
Recurrent Adult Primary Liver Cancer
Recurrent Extrahepatic Bile Duct Cancer
Stage D Adult Primary Liver Cancer (BCLC)
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: PET scan
Procedure: CT Scan
Procedure: hepatic artery embolization

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Intrinsic Dosimetry for Radioembolization Utilizing PET-CT Imaging Data: A Prospective Registry Study

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Radiation dose to 70% of the tumor volume, evaluated using PET-CT [ Time Frame: Up to day 1 ] [ Designated as safety issue: No ]
    Standard summary measures such as means, medians, ranges, and standard deviations will be used to characterize the dosages received by tumor and other tissue. The relationship between radiation dose and local control will be determined using regression models with Generalized Estimating Equations (GEE) to account for within-patient correlation. Logistic regression will be used to adjust for potentially confounding factors such as tumor volume, primary histology, and SIR-Spheres versus Therasphere intervention.

  • Local control [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    The relationship between radiation dose and local control will be determined using regression models with GEE to account for within-patient correlation.


Secondary Outcome Measures:
  • Ability of PET-CT to reproducibly determine dose to tumor, normal liver, and other surrounding organs [ Time Frame: Up to day 1 ] [ Designated as safety issue: No ]
    Standard summary measures such as means, medians, ranges, and standard deviations will be used to characterize the dosages received by tumor and other tissue.

  • Side effects of radiation dose to healthy tissue such as fatigue, nausea, pain, and elevated liver function tests [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Each side effect will be characterized as present or absent. The relationship between radiation dose to the relevant type of healthy tissue and each side effect will be tested.

  • Distribution of activity measured by PET-CT [ Time Frame: Up to day 1 ] [ Designated as safety issue: No ]
    Differences between PET-CT and MAA doses, and present the data graphically will be calculated and presented graphically. The method proposed by Bland & Altman (2007) will be used to assess the agreement between the two methods.

  • Distribution predicted by T-99m labeled MAA [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Differences between PET-CT and MAA doses, and present the data graphically will be calculated and presented graphically. The method proposed by Bland & Altman (2007) will be used to assess the agreement between the two methods.

  • Change in dose measured by PET-CT scan [ Time Frame: Day 0 to day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: February 2014
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic: PET scan - CT scan
Patients undergo PET-CT scan before and after standard radioembolization on day 0. A subset of patients undergo PET-CT scan on day 1, 24 hours after the day 0 post-treatment PET-CT.
Procedure: PET scan
Undergo PET-CT scan
Other Name: FDG-PET, positron emission tomography, emission computed
Procedure: CT Scan
Undergo PET-CT scan
Other Name: computed tomography, computed
Procedure: hepatic artery embolization
Undergo standard radioembolization

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the relationship between radiation dose to 70% of the tumor volume as determined by post-treatment positron emission tomography (PET)-computed tomography (CT) and local control at 6 months.

SECONDARY OBJECTIVES:

I. To evaluate the ability of PET-CT to reproducibly determine dose to tumor, normal liver, and other surrounding organs.

II. To determine the stability of microsphere location by examining the changes in dose in a subset of patients with PET-CT scans performed on day 0 and day 1.

III. To determine the relationship of dose predicted by technetium-99m (Tc-99m) labeled Macro-aggregated albumin (MAA) imaged using single-photon emission computed tomography (SPECT) versus post-treatment dosimetry.

IV. To determine the effect of dose delivered on local control and normal tissue complications.

V. To measure the perfusion of the tumor for correlation with dose deposition, based on arterial phase CT measurements.

OUTLINE:

Patients undergo PET-CT scan before and after standard radioembolization on day 0. A subset of patients undergo PET-CT scan on day 1, 24 hours after the day 0 post-treatment PET-CT.

After completion of study treatment, patients are followed up at 1 week, 1 and 3 months, every 3 months for 1 year, every 6 months for 1 year and then annually for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have liver-dominant or liver-only metastatic disease from any primary histology; patients with primary hepatocellular or biliary cancer are also eligible
  • Patients must be clinical candidates for radioembolization with either SIR-spheres or TheraSphere due to metastatic or primary malignancies of the liver
  • Women of child bearing potential must have a negative serum pregnancy test no more than 72 hours prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
  • Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of medical information
  • Complete blood count (CBC) and chemistry panel (CMP) no greater than 4 weeks prior to visit 1
  • Diagnostic imaging of the abdomen utilizing either CT with contrast, magnetic resonance imaging (MRI), or PET/CT no greater than 4 weeks prior to visit 1

Exclusion Criteria:

  • Patients not undergoing radioembolization to the liver
  • Women of childbearing potential (WOCBP) and men who refuse to comply with appropriate contraception
  • Women who are either pregnant or breast feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02088775

Contacts
Contact: Joshua Meyer, MD 215-728-2667 joshua.meyer@fccc.edu

Locations
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Joshua Meyer, MD    215-728-2667    joshua.meyer@fccc.edu   
Sub-Investigator: Jian Qin (Michael) Yu, MD         
Principal Investigator: Joshua Meyer, MD         
Sub-Investigator: Mohan Doss, MD         
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Joshua Meyer, MD Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT02088775     History of Changes
Other Study ID Numbers: ERP-RT-060, IRB#13-030
Study First Received: March 13, 2014
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Bile Duct Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014