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

NCT02088775 | Completed DMC

• 2 other identifiers: ERP-RT-060IRB#13-030
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Radiation dose to 70% of the tumor volume, evaluated using PET-CT

  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.

  Up to day 1

• Local control

  The relationship between radiation dose and local control will be determined using regression models with GEE to account for within-patient correlation.

  At 6 months

Secondary Outcomes (5)

• Ability of PET-CT to reproducibly determine dose to tumor, normal liver, and other surrounding organs

  Up to day 1

• Side effects of radiation dose to healthy tissue such as fatigue, nausea, pain, and elevated liver function tests

  Up to 5 years

• Distribution of activity measured by PET-CT

  Up to day 1

• Distribution predicted by T-99m labeled MAA

  Baseline

• Change in dose measured by PET-CT scan

  Day 0 to day 1

Study Arms (1)

Diagnostic: PET scan - CT scan

EXPERIMENTAL

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; Procedure: CT Scan; Procedure: hepatic artery embolization

Interventions

PET scan PROCEDURE

Undergo PET-CT scan

Also known as: FDG-PET, positron emission tomography, emission computed

Diagnostic: PET scan - CT scan

CT Scan PROCEDURE

Undergo PET-CT scan

Also known as: computed tomography, computed

Diagnostic: PET scan - CT scan

hepatic artery embolization PROCEDURE

Undergo standard radioembolization

Diagnostic: PET scan - CT scan

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Bile Duct Neoplasms

Interventions

Magnetic Resonance Spectroscopy

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; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Joshua Meyer, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 17, 2014
• Study Start: February 1, 2014
• Primary Completion: August 8, 2016
• Study Completion: July 30, 2021
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

US (1)