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.
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
- Conditions the study is for
- Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Metastatic Extrahepatic Bile Duct Cancer
- 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
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
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:
- 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:
- 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.
- 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
- 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)
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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
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)
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
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
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
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
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.
- First posted17 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completion8 Aug 2016
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Primary Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Meyer, MD, Principal investigator, Fox Chase Cancer Center
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