Clinical trial NCT02088775: PET-CT in Determining the Radioembolization Dose Delivered to Patients With Liver Metastasis, Primary Liver Cancer, or Biliary Cancer
Official title: Intrinsic Dosimetry for Radioembolization Utilizing PET-CT Imaging Data: A Prospective Registry Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Radiation dose to 70% of the tumor volume, evaluated using PET-CT
timeFrame: Up to day 1
measure: Local control
timeFrame: At 6 months
Secondary outcomes:
measure: Ability of PET-CT to reproducibly determine dose to tumor, normal liver, and other surrounding organs
timeFrame: Up to day 1
measure: Side effects of radiation dose to healthy tissue such as fatigue, nausea, pain, and elevated liver function tests
timeFrame: Up to 5 years
measure: Distribution of activity measured by PET-CT
timeFrame: Up to day 1
measure: Distribution predicted by T-99m labeled MAA
timeFrame: Baseline
measure: Change in dose measured by PET-CT scan
timeFrame: Day 0 to day 1
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Joshua Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References: