Hepatocellular CarcinomaNCT03686709
Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
A study testing Post therapy PET/CT Imaging in people with Hepatocellular Carcinoma and Radiation Exposure, run by University of Tennessee at 1 site in United States.
Trial summary
The objective of this study is to examine critical aspects of radiation exposure, dose delivery, and systemic yttrium-90 (Y90) exposure related to the infusion of Y90 microspheres for treatment of hepatocellular carcinoma (HCC) and other metastatic liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Radiation Exposure
- What is being tested?
- Post therapy PET/CT Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All patients undergoing Y90 radioembolization therapy with SIR-Spheres or TheraSpheres are eligible to participate in this study
- Must be able to schedule and tolerate additional PET/CT imaging following therapy
- Must be able to tolerate additional blood draws before, during, and after the radioembolization therapy procedure.
Who cannot join
- Patients that are not candidates for Y90 radioembolization therapy
- Patients that cannot tolerate additional imaging procedures following therapy
- Patients that cannot tolerate the additional blood draws required for this study
- Patients whose schedule does not allow them to remain at the hospital for the additional PET/CT imaging study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Melissa Weaver, 865-305-6181, mweaver@utmck.edu
Shelley Acuff, 8653056312, sacuff@utmck.edu
About this study
The objective of this study is to examine critical aspects of radiation exposure, dose delivery, and systemic yttrium-90 (Y90) exposure related to the infusion of Y90 microspheres for treatment of hepatocellular carcinoma (HCC) and other metastatic liver disease.
Read the detailed description
Radioembolization using Y90 microspheres is a relatively new therapy option for patients with hepatocellular carcinoma (HCC) or other metastatic disease. This process requires the injection of radioactive beta-emitting spheres to delivery a targeted dose to the lesion resulting in cell death. With this technology comes many questions related to the safety and handling and usage of these products. This study will focus on three key aspects of dose delivery using these products.
The first aim will examine radiation exposure to staff that are involved in handling Y90 microspheres. Radiation exposure to employees has only been somewhat addressed with a recent publication in the European Journal of Nuclear Medicine. Although this work contained key information for assessing exposure, the methods used were characteristic of european clinics and do not mirror the typical workflows seen in North American facilities. In this study, we will use new dosimeter technology to examine radiation exposure to the hands and body of the following clinical personnel using both TheraSphere and SIR-Spheres technology:
- Nuclear medicine technologists: responsible for drawing up, transporting, and disposal of Y90 microspheres doses.
- Interventional radiologists: responsible for administration of Y90 microspheres doses
The second aim will examine the use of a modular and portable detector device to provide real-time monitoring of radiation fields surrounding the microsphere administration systems. With current workflows, the final confirmation of whether the full dose was delivered is not assessed until after the procedure is completed and residual vial activities measured. This work will examine if this type of device might be useful in providing a real-time determination of whether the prescribed Y90 microspheres dose was fully delivered to the patient. Detectors will be placed at points throughout the delivery system and data recorded before, during, and after the injection of Y90. Time activity curves will be generated and assessed to determine activity levels near the dose vial and through distribution lines as the dose is injected. We will use various analysis techniques to identify and characterize the injection to determine if a dose administration was successful prior to removing the patient from the procedure room.
The third aim will use a modular detector device as well as post-radioembolization PET/CT to examine leaching of free Y90 following injection of Y90 microspheres. Some degree of leaching is expected with any labeled product, however, the degree of leaching involved with Y90 microspheres in vivo has yet to be studied in any detail. This pilot study will use two techniques to assess the impact and degree of leaching during Y90 dose administration.
The first step will use the modular detector device used in aim two of this proposal to measure radioactivity before, during, and after the Y90 dose administration. Detectors will be placed near the patient skin surface in close proximity to the lesion(s) being treated, as well as location distal to the catheter location in other body areas, including the extremities. Time activity curves will be generated from the data collected which will enable analysis of on-target and off-target activity. This data may also be used to assess flow kinetics which may improve isolation of the cause or route of leached Y90 should it be found.
The second step will involve imaging the patients using PET/CT. Typical Y90 radioembolization focuses on only imaging the liver for assessment of dosimetry following the dose administration. In this study, we will acquire a longer axial PET/CT covering an anatomical range from the top of the head to the lower extremities. This is equivalent to a typical PET/CT protocol used in melanoma imaging. The CT used will be a low-dose CT used only for anatomical localization and PET attenuation correction while the PET acquisition will only use the on-board Y90 for imaging and will not add any additional patient dose.
Using these two methods, we hope to monitor and assess leaching both during and after Y90 radioembolization to determine key concerns, such as the following:
- The frequency of detectable levels of leaching
- Physical extent of leaching throughout the body
- Patient radiation dose estimates associated with the leaching phenomenon
- Conditions
- Hepatocellular Carcinoma, Radiation Exposure
- Being tested
- Post therapy PET/CT Imaging
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post therapy PET/CT ImagingDiagnostic test
whole-body PET/CT following Y90 radioembolization
| Study group | Role | What they receive |
|---|---|---|
| SIR-Spheres Therapy Selection | Experimental | Patient selected for SIR-spheres radioembolization therapy using standard of care selection. Infusion of the therapy dose will be monitored using external detectors placed on the delivery system as well as the points on the patient. Blood draws will be collected before, during, and after the therapy infusion to monitor radiation levels in the blood. Following therapy, the patient will undergo standard of care bremsstrahlung SPECT imaging as well post-infusion PET/CT. A final blood draw will take place in conjunction with PET/CT imaging. Receives: Diagnostic Test: Post therapy PET/CT Imaging |
| TheraSpheres Therapy Selection | Experimental | Patient selected for TheraSpheres radioembolization therapy using standard of care selection. Infusion of the therapy dose will be monitored using external detectors placed on the delivery system as well as the points on the patient. Blood draws will be collected before, during, and after the therapy infusion to monitor radiation levels in the blood. Following therapy, the patient will undergo standard of care bremsstrahlung SPECT imaging as well post-infusion PET/CT. A final blood draw will take place in conjunction with PET/CT imaging. Receives: Diagnostic Test: Post therapy PET/CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Active Dose Delivery Monitoring
This outcome will be measured using modular detector devices placed on the Y90 dose delivery system as well as on the patient. These radiation detectors monitor radiation in real-time during the dose infusion. Time activity curves from the detectors will be collected and assessed for determining if the full dose was delivered as intended.
Measured: During therapy delivery: ~30 minutes
Measurement and Assessment of Free, Circulating Yttrium 90
This outcome measure will examine the ability to measure free Y90 in the blood during routine therapy procedures. This outcome will be monitored by both modular radiation detectors placed on the patient as well as through blood samples taken before, during, and after the infusion of the therapy dose. An initial blood draw prior to the delivery of the Y90 therapy will provide a baseline for each patient. Samples taken during and after infusion will provide key insights into the changes in blood radioactivity levels which will correspond to the infusion of Y90 and subsequently, the free Y90 circulating in the blood that was not directed to the tumor.
Measured: Before, during, and after therapy delivery as well as in conjunction with PET/CT: ~40 minutes
Therapy Monitoring Using Whole-Body Post-therapy PET/CT Imaging
This outcome measure will examine the final treatment biodistribution using PET/CT imaging for visual analysis of the data to assess the distribution of spheres within the site of delivery.
Measured: Following Y90 radioembolization therapy: ~30-40 minutes 2-4 hours post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start19 Jun 2018
- Primary completion18 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a feasibility study assessing radiation exposure and distribution of Y90 therapy agents. Two groups of 10 patients will be recruited with equal numbers in each group for each of the two types of Y90 radioembolization products commercially available in the United States.Both groups undergo the same monitoring procedures throughout the study and then will be compared. Stratification of patients into therapy groups is solely based on clinical standard of care decision making.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Responsible party
- Sponsor
- Investigators
- Dustin Osborne, PhD, Principal investigator, University of TennesseeChristopher Stephens, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686709
- Sponsor's protocol ID
- 4388
- Status last verified
- Jun 2018
- First submitted
- 5 Jul 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Data currently will not be shared but could potentially be shared in the future.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
- ClinicalTrials.gov ID
- NCT03686709
- Acronym / sponsor ID
- 4388
- Conditions
- Hepatocellular Carcinoma, Radiation Exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 18 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to examine critical aspects of radiation exposure, dose delivery, and systemic yttrium-90 (Y90) exposure related to the infusion of Y90 microspheres for treatment of hepatocellular carcinoma (HCC) and other metastatic liver disease.
Detailed description
Radioembolization using Y90 microspheres is a relatively new therapy option for patients with hepatocellular carcinoma (HCC) or other metastatic disease. This process requires the injection of radioactive beta-emitting spheres to delivery a targeted dose to the lesion resulting in cell death. With this technology comes many questions related to the safety and handling and usage of these products. This study will focus on three key aspects of dose delivery using these products.
The first aim will examine radiation exposure to staff that are involved in handling Y90 microspheres. Radiation exposure to employees has only been somewhat addressed with a recent publication in the European Journal of Nuclear Medicine. Although this work contained key information for assessing exposure, the methods used were characteristic of european clinics and do not mirror the typical workflows seen in North American facilities. In this study, we will use new dosimeter technology to examine radiation exposure to the hands and body of the following clinical personnel using both TheraSphere and SIR-Spheres technology:
- Nuclear medicine technologists: responsible for drawing up, transporting, and disposal of Y90 microspheres doses.
- Interventional radiologists: responsible for administration of Y90 microspheres doses
The second aim will examine the use of a modular and portable detector device to provide real-time monitoring of radiation fields surrounding the microsphere administration systems. With current workflows, the final confirmation of whether the full dose was delivered is not assessed until after the procedure is completed and residual vial activities measured. This work will examine if this type of device might be useful in providing a real-time determination of whether the prescribed Y90 microspheres dose was fully delivered to the patient. Detectors will be placed at points throughout the delivery system and data recorded before, during, and after the injection of Y90. Time activity curves will be generated and assessed to determine activity levels near the dose vial and through distribution lines as the dose is injected. We will use various analysis techniques to identify and characterize the injection to determine if a dose administration was successful prior to removing the patient from the procedure room.
The third aim will use a modular detector device as well as post-radioembolization PET/CT to examine leaching of free Y90 following injection of Y90 microspheres. Some degree of leaching is expected with any labeled product, however, the degree of leaching involved with Y90 microspheres in vivo has yet to be studied in any detail. This pilot study will use two techniques to assess the impact and degree of leaching during Y90 dose administration.
The first step will use the modular detector device used in aim two of this proposal to measure radioactivity before, during, and after the Y90 dose administration. Detectors will be placed near the patient skin surface in close proximity to the lesion(s) being treated, as well as location distal to the catheter location in other body areas, including the extremities. Time activity curves will be generated from the data collected which will enable analysis of on-target and off-target activity. This data may also be used to assess flow kinetics which may improve isolation of the cause or route of leached Y90 should it be found.
The second step will involve imaging the patients using PET/CT. Typical Y90 radioembolization focuses on only imaging the liver for assessment of dosimetry following the dose administration. In this study, we will acquire a longer axial PET/CT covering an anatomical range from the top of the head to the lower extremities. This is equivalent to a typical PET/CT protocol used in melanoma imaging. The CT used will be a low-dose CT used only for anatomical localization and PET attenuation correction while the PET acquisition will only use the on-board Y90 for imaging and will not add any additional patient dose.
Using these two methods, we hope to monitor and assess leaching both during and after Y90 radioembolization to determine key concerns, such as the following:
- The frequency of detectable levels of leaching
- Physical extent of leaching throughout the body
- Patient radiation dose estimates associated with the leaching phenomenon
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a feasibility study assessing radiation exposure and distribution of Y90 therapy agents. Two groups of 10 patients will be recruited with equal numbers in each group for each of the two types of Y90 radioembolization products commercially available in the United States.Both groups undergo the same monitoring procedures throughout the study and then will be compared. Stratification of patients into therapy groups is solely based on clinical standard of care decision making.
| Arm | Type | Receives |
|---|---|---|
| SIR-Spheres Therapy Selection | Experimental | Diagnostic Test: Post therapy PET/CT ImagingPatient selected for SIR-spheres radioembolization therapy using standard of care selection. Infusion of the therapy dose will be monitored using external detectors placed on the delivery system as well as the points on the patient. Blood draws will be collected before, during, and after the therapy infusion to monitor radiation levels in the blood. Following therapy, the patient will undergo standard of care bremsstrahlung SPECT imaging as well post-infusion PET/CT. A final blood draw will take place in conjunction with PET/CT imaging. |
| TheraSpheres Therapy Selection | Experimental | Diagnostic Test: Post therapy PET/CT ImagingPatient selected for TheraSpheres radioembolization therapy using standard of care selection. Infusion of the therapy dose will be monitored using external detectors placed on the delivery system as well as the points on the patient. Blood draws will be collected before, during, and after the therapy infusion to monitor radiation levels in the blood. Following therapy, the patient will undergo standard of care bremsstrahlung SPECT imaging as well post-infusion PET/CT. A final blood draw will take place in conjunction with PET/CT imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients undergoing Y90 radioembolization therapy with SIR-Spheres or TheraSpheres are eligible to participate in this study
- Must be able to schedule and tolerate additional PET/CT imaging following therapy
- Must be able to tolerate additional blood draws before, during, and after the radioembolization therapy procedure.
Key exclusion criteria (4 listed)
- Patients that are not candidates for Y90 radioembolization therapy
- Patients that cannot tolerate additional imaging procedures following therapy
- Patients that cannot tolerate the additional blood draws required for this study
- Patients whose schedule does not allow them to remain at the hospital for the additional PET/CT imaging study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post therapy PET/CT Imagingwhole-body PET/CT following Y90 radioembolization | Diagnostic test | SIR-Spheres Therapy Selection, TheraSpheres Therapy Selection |
Primary outcome
Feasibility of Active Dose Delivery Monitoring
Time frame: During therapy delivery: ~30 minutes
This outcome will be measured using modular detector devices placed on the Y90 dose delivery system as well as on the patient. These radiation detectors monitor radiation in real-time during the dose infusion. Time activity curves from the detectors will be collected and assessed for determining if the full dose was delivered as intended.
Measurement and Assessment of Free, Circulating Yttrium 90
Time frame: Before, during, and after therapy delivery as well as in conjunction with PET/CT: ~40 minutes
This outcome measure will examine the ability to measure free Y90 in the blood during routine therapy procedures. This outcome will be monitored by both modular radiation detectors placed on the patient as well as through blood samples taken before, during, and after the infusion of the therapy dose. An initial blood draw prior to the delivery of the Y90 therapy will provide a baseline for each patient. Samples taken during and after infusion will provide key insights into the changes in blood radioactivity levels which will correspond to the infusion of Y90 and subsequently, the free Y90 circulating in the blood that was not directed to the tumor.
Therapy Monitoring Using Whole-Body Post-therapy PET/CT Imaging
Time frame: Following Y90 radioembolization therapy: ~30-40 minutes 2-4 hours post-therapy
This outcome measure will examine the final treatment biodistribution using PET/CT imaging for visual analysis of the data to assess the distribution of spheres within the site of delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: Undecided. Data currently will not be shared but could potentially be shared in the future.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dustin Osborne, PhD principal investigator
University of Tennessee
Christopher Stephens, MD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post therapy PET/CT Imaging in people with Hepatocellular Carcinoma and Radiation Exposure, run by University of Tennessee 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Sep 2018. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dustin Osborne, PhD (8653058264, dosborne@utmck.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Active Dose Delivery Monitoring (time frame: During therapy delivery: ~30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2018.