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Adult Primary Hepatocellular CarcinomaNCT02088775

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

A study testing PET scan, CT Scan and hepatic artery embolization in people with Adult Primary Hepatocellular Carcinoma and Advanced Adult Primary Liver Cancer, run by Fox Chase Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PET scan, CT Scan and hepatic artery embolization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
Feb 2014to 30 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: Intrinsic Dosimetry for Radioembolization Utilizing PET-CT Imaging Data: A Prospective Registry Study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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.

Although the study uses radiation-emitting imaging devices (PET/CT and SPECT) and standard-of-care Y-90 radioembolization, the clinical investigation does not study the performance, effect, safety, effectiveness, design, or intended use of an FDA-regulated device product. The research objectives are limited to characterization of radiation dose distribution and correlation of dosimetry with clinical outcomes; therefore, the study does not "Study a U.S. FDA-regulated Device Product" within the meaning of 42 CFR Part 11

Being tested
PET scan, CT Scan, hepatic artery embolization
Medical subject headings
Carcinoma, Hepatocellular, Bile Duct Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET scanProcedure or surgery

    Also called FDG-PET, positron emission tomography, emission computed

    Undergo PET-CT scan

  • CT ScanProcedure or surgery

    Also called computed tomography, computed

    Undergo PET-CT scan

  • hepatic artery embolizationProcedure or surgery

    Undergo standard radioembolization

Study groups in NCT02088775
Study groupRoleWhat they receive
Diagnostic: PET scan - CT scanExperimentalPatients 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.
Receives: Procedure: PET scan; Procedure: CT Scan; Procedure: hepatic artery embolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to day 1

  2. Local control

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

    Measured: At 6 months

Secondary outcomes (5)

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

    Standard summary measures such as means, medians, ranges, and standard deviations will be used to characterize the dosages received by tumor and other tissue.

    Measured: Up to day 1

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

    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.

    Measured: Up to 5 years

  3. Distribution of activity measured by PET-CT

    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.

    Measured: Up to day 1

  4. Distribution predicted by T-99m labeled MAA

    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.

    Measured: Baseline

  5. Change in dose measured by PET-CT scan

    Measured: Day 0 to day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completion8 Aug 2016
  4. Study completion30 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02088775
Sponsor's protocol ID
ERP-RT-060
Other IDs
IRB#13-030
Status last verified
Jun 2026
First submitted
13 Mar 2014
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing PET scan, CT Scan and hepatic artery embolization in people with Adult Primary Hepatocellular Carcinoma and Advanced Adult Primary Liver Cancer, run by Fox Chase Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiation dose to 70% of the tumor volume, evaluated using PET-CT (time frame: Up to day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02088775.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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