Hepatocellular CarcinomaNCT02558205
Correlation Between CT Perfusion and Post Y-90 TARE PET/CT Dosimetry
An observational study of Hepatocellular Carcinoma, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to see if it is possible to establish a relationship between the blood flow and blood volume of liver tumors from CT body perfusion and the radiation dose deposited in the tumors from the radioembolization treatment as measured by PET/CT. The study will do this by: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- CT Liver Perfusion and PET/CT of liver
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2020
- Phase
- Observational
- 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
Study population: Patients identified for Y-90 transarterial radioembolization of liver tumors with hepatocellular carcinoma
Who may be able to join
- Hepatocellular Carcinoma diagnosis
- Candidate for Trans-Arterial Radioembolization treatment
Who cannot join
- Less than 18 years old
- Pregnant
- Iodinated Contrast Agent Allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Establishing a Correlation Between Pre-treatment CT Perfusion Parameter Values and Post-treatment PET/CT Dosimetry to Aid in Tumor-specific Y-90 Radioembolization Treatment Planning for Hepatocellular Carcinoma
The purpose of this study is to see if it is possible to establish a relationship between the blood flow and blood volume of liver tumors from CT body perfusion and the radiation dose deposited in the tumors from the radioembolization treatment as measured by PET/CT.
The study will do this by:
Read more
- Measuring the blood flow and blood volume of tumors in the imaging data from a CT body perfusion
- Measuring the radioactivity in the tumors after the radioembolization treatment using PET/CT and then calculating the dose deposited in the tumor
- Using statistical analysis to assess the relationship between the dose and the perfusion parameters
In addition, the research may help develop a method for calculating the dose of radioembolization to be delivered to a liver tumor(s) using blood volume and blood flow data obtained from the CT body perfusion scans.
Read the detailed description
The overreaching goal of this line of research is to establish a methodology to produce patient and tumor specific treatment planning for Yttrium-90 radioembolization of hepatocellular carcinoma (HCC). The proposed project will facilitate the collection of preliminary data to support a larger study to more fully establish the relationship between tumor perfusion parameters and delivered radiation dose. Y-90 radioembolization delivers millions of small resin or glass beads attached to or containing (depending on the product) the beta emitting radioisotope of Yttrium. These beads are injected into the patient's hepatic artery during an interventional radiology procedure. The beads are pushed into the hepatic vasculature system by pulsatile flow and eventually become lodged, due to their finite size, in the microvasculature of the liver and tumor and deliver the radiation dose from the high energy beta particles (average energy 0.94 MeV) released during the radioactive decay (half life of 64 hours) in a highly local (~2.5 mm range) manner. The beads are permanently embedded in the vasculature and the radioactivity eventually decays to background.
Current practice is to calculate and deliver an average liver lobe radiation dose based on either the lobar volume or the patient's body surface area. However, because of the hypervascular nature of HCC lesions, the tumors receive a greater proportion of the beads than the healthy liver parenchyma and hence are assumed to receive radiation doses well above that of calculated average liver dose and the dose to the normal liver. Due to the differing vascularity and characteristics of tumors and patients, each Y-90 treatment does not deliver the same dose to the tumor. A less vascular tumor may receive substantially less radiation than a more vascular one which affects the tumoricidal efficacy of the treatment and ultimately the patient's final outcome. New techniques using Positron Emission Tomography (PET)/CT following Y-90 treatment allow for retrospective dosimetry to determine the actual dose delivered to the tumor. However, no methodology exists to plan the dose to be delivered to the tumor prior to the treatment.
This research aims to collect preliminary data to begin to establish a prospective method to use Computed Tomography (CT) perfusion studies of the liver to calculate the expected dose to the HCC lesions and the normal liver based on the blood flow and blood volume. This goal will be achieved by prospectively collecting CT Perfusion studies prior to Y-90 radioembolization treatments and PET/CT immediately following treatments. The relationship between the perfusion parameters representing the vascularity of the lesions and the normal liver and the post treatment PET/CT dosimetry will be established by this line of research. The hypothesized correlation between the perfusion parameters and the tumor dose as established by PET/CT will allow for patient and tumor specific treatment planning ensuring that the appropriate tumoricidal radiation dose is reliably delivered.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- CT Liver Perfusion, PET/CT of liver
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Liver PerfusionRadiation
Imaging study of liver using injection of Iodine contrast agent done using CT imaging
PET/CT of liverRadiation
PET/CT of liver following Y-90 treatment. PET/CT imaging uses positron decay of Y-90 to detect distribution of Y-90 in the liver.
| Study group | Role | What they receive |
|---|---|---|
| CT Perfusion and PET/CT | Patients undergo both a CT liver perfusion study pre Y-90 treatment and a PET/CT of liver following Y-90 treatment. For the PET/CT no additional radioactivity is required. Receives: Radiation: CT Liver Perfusion; Radiation: PET/CT of liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of CT perfusion metrics to radiation dose deposition of Y-90 as measured by PET/CT
Measured: 1 year
Secondary outcomes (1)
Correlation between CT perfusion metrics and post treatment response as measured by RECIST 1.0 criteria
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJul 2015 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: unable to rectuir
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Swim Across America
- Responsible party
- Sponsor
- Investigators
- Mark P Supanich, Ph.D., Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558205
- Sponsor's protocol ID
- 14100902
- Status last verified
- Oct 2020
- First submitted
- 22 Sep 2015
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Frampas E, Lassau N, Zappa M, Vullierme MP, Koscielny S, Vilgrain V. Advanced Hepatocellular Carcinoma: early evaluation of response to targeted therapy and prognostic value of Perfusion CT and Dynamic Contrast Enhanced-Ultrasound. Preliminary results. Eur J Radiol. 2013 May;82(5):e205-11. doi: 10.1016/j.ejrad.2012.12.004. Epub 2012 Dec 28.
PubMed 23273822Morsbach F, Sah BR, Spring L, Puippe G, Gordic S, Seifert B, Schaefer N, Pfammatter T, Alkadhi H, Reiner CS. Perfusion CT best predicts outcome after radioembolization of liver metastases: a comparison of radionuclide and CT imaging techniques. Eur Radiol. 2014 Jul;24(7):1455-65. doi: 10.1007/s00330-014-3180-3. Epub 2014 May 12.
PubMed 24817083Lea WB, Tapp KN, Tann M, Hutchins GD, Fletcher JW, Johnson MS. Microsphere localization and dose quantification using positron emission tomography/CT following hepatic intraarterial radioembolization with yttrium-90 in patients with advanced hepatocellular carcinoma. J Vasc Interv Radiol. 2014 Oct;25(10):1595-603. doi: 10.1016/j.jvir.2014.06.028. Epub 2014 Aug 23.
PubMed 25156647Bourgeois AC, Chang TT, Bradley YC, Acuff SN, Pasciak AS. Intraprocedural yttrium-90 positron emission tomography/CT for treatment optimization of yttrium-90 radioembolization. J Vasc Interv Radiol. 2014 Feb;25(2):271-5. doi: 10.1016/j.jvir.2013.11.004.
PubMed 24461132D'Arienzo M, Filippi L, Chiaramida P, Chiacchiararelli L, Cianni R, Salvatori R, Scopinaro F, Bagni O. Absorbed dose to lesion and clinical outcome after liver radioembolization with 90Y microspheres: a case report of PET-based dosimetry. Ann Nucl Med. 2013 Aug;27(7):676-80. doi: 10.1007/s12149-013-0726-4. Epub 2013 Apr 20.
PubMed 23605058
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Correlation Between Pre-treatment CT Perfusion Parameter Values and Post-treatment PET/CT Dosimetry to Aid in Tumor-specific Y-90 Radioembolization Treatment Planning for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02558205
- Acronym / sponsor ID
- 14100902
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: unable to rectuir
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Swim Across America
- Study start
- Jul 2015 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 23 Sep 2015 (estimated)
- 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 purpose of this study is to see if it is possible to establish a relationship between the blood flow and blood volume of liver tumors from CT body perfusion and the radiation dose deposited in the tumors from the radioembolization treatment as measured by PET/CT.
The study will do this by:
- Measuring the blood flow and blood volume of tumors in the imaging data from a CT body perfusion
- Measuring the radioactivity in the tumors after the radioembolization treatment using PET/CT and then calculating the dose deposited in the tumor
- Using statistical analysis to assess the relationship between the dose and the perfusion parameters
In addition, the research may help develop a method for calculating the dose of radioembolization to be delivered to a liver tumor(s) using blood volume and blood flow data obtained from the CT body perfusion scans.
Detailed description
The overreaching goal of this line of research is to establish a methodology to produce patient and tumor specific treatment planning for Yttrium-90 radioembolization of hepatocellular carcinoma (HCC). The proposed project will facilitate the collection of preliminary data to support a larger study to more fully establish the relationship between tumor perfusion parameters and delivered radiation dose. Y-90 radioembolization delivers millions of small resin or glass beads attached to or containing (depending on the product) the beta emitting radioisotope of Yttrium. These beads are injected into the patient's hepatic artery during an interventional radiology procedure. The beads are pushed into the hepatic vasculature system by pulsatile flow and eventually become lodged, due to their finite size, in the microvasculature of the liver and tumor and deliver the radiation dose from the high energy beta particles (average energy 0.94 MeV) released during the radioactive decay (half life of 64 hours) in a highly local (~2.5 mm range) manner. The beads are permanently embedded in the vasculature and the radioactivity eventually decays to background.
Current practice is to calculate and deliver an average liver lobe radiation dose based on either the lobar volume or the patient's body surface area. However, because of the hypervascular nature of HCC lesions, the tumors receive a greater proportion of the beads than the healthy liver parenchyma and hence are assumed to receive radiation doses well above that of calculated average liver dose and the dose to the normal liver. Due to the differing vascularity and characteristics of tumors and patients, each Y-90 treatment does not deliver the same dose to the tumor. A less vascular tumor may receive substantially less radiation than a more vascular one which affects the tumoricidal efficacy of the treatment and ultimately the patient's final outcome. New techniques using Positron Emission Tomography (PET)/CT following Y-90 treatment allow for retrospective dosimetry to determine the actual dose delivered to the tumor. However, no methodology exists to plan the dose to be delivered to the tumor prior to the treatment.
This research aims to collect preliminary data to begin to establish a prospective method to use Computed Tomography (CT) perfusion studies of the liver to calculate the expected dose to the HCC lesions and the normal liver based on the blood flow and blood volume. This goal will be achieved by prospectively collecting CT Perfusion studies prior to Y-90 radioembolization treatments and PET/CT immediately following treatments. The relationship between the perfusion parameters representing the vascularity of the lesions and the normal liver and the post treatment PET/CT dosimetry will be established by this line of research. The hypothesized correlation between the perfusion parameters and the tumor dose as established by PET/CT will allow for patient and tumor specific treatment planning ensuring that the appropriate tumoricidal radiation dose is reliably delivered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT Perfusion and PET/CT | – | Radiation: CT Liver Perfusion, Radiation: PET/CT of liverPatients undergo both a CT liver perfusion study pre Y-90 treatment and a PET/CT of liver following Y-90 treatment. For the PET/CT no additional radioactivity is required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients identified for Y-90 transarterial radioembolization of liver tumors with hepatocellular carcinoma
Key inclusion criteria (2 listed)
- Hepatocellular Carcinoma diagnosis
- Candidate for Trans-Arterial Radioembolization treatment
Key exclusion criteria (3 listed)
- Less than 18 years old
- Pregnant
- Iodinated Contrast Agent Allergy
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 |
|---|---|---|
| CT Liver PerfusionImaging study of liver using injection of Iodine contrast agent done using CT imaging | Radiation | CT Perfusion and PET/CT |
| PET/CT of liverPET/CT of liver following Y-90 treatment. PET/CT imaging uses positron decay of Y-90 to detect distribution of Y-90 in the liver. | Radiation | CT Perfusion and PET/CT |
Primary outcome
Correlation of CT perfusion metrics to radiation dose deposition of Y-90 as measured by PET/CT
Time frame: 1 year
1 secondary outcome
Correlation between CT perfusion metrics and post treatment response as measured by RECIST 1.0 criteria
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 23273822Frampas E, Lassau N, Zappa M, Vullierme MP, Koscielny S, Vilgrain V. Advanced Hepatocellular Carcinoma: early evaluation of response to targeted therapy and prognostic value of Perfusion CT and Dynamic Contrast Enhanced-Ultrasound. Preliminary results. Eur J Radiol. 2013 May;82(5):e205-11. doi: 10.1016/j.ejrad.2012.12.004. Epub 2012 Dec 28.
- Background: PubMed 24817083Morsbach F, Sah BR, Spring L, Puippe G, Gordic S, Seifert B, Schaefer N, Pfammatter T, Alkadhi H, Reiner CS. Perfusion CT best predicts outcome after radioembolization of liver metastases: a comparison of radionuclide and CT imaging techniques. Eur Radiol. 2014 Jul;24(7):1455-65. doi: 10.1007/s00330-014-3180-3. Epub 2014 May 12.
- Background: PubMed 25156647Lea WB, Tapp KN, Tann M, Hutchins GD, Fletcher JW, Johnson MS. Microsphere localization and dose quantification using positron emission tomography/CT following hepatic intraarterial radioembolization with yttrium-90 in patients with advanced hepatocellular carcinoma. J Vasc Interv Radiol. 2014 Oct;25(10):1595-603. doi: 10.1016/j.jvir.2014.06.028. Epub 2014 Aug 23.
- Background: PubMed 24461132Bourgeois AC, Chang TT, Bradley YC, Acuff SN, Pasciak AS. Intraprocedural yttrium-90 positron emission tomography/CT for treatment optimization of yttrium-90 radioembolization. J Vasc Interv Radiol. 2014 Feb;25(2):271-5. doi: 10.1016/j.jvir.2013.11.004.
- Background: PubMed 23605058D'Arienzo M, Filippi L, Chiaramida P, Chiacchiararelli L, Cianni R, Salvatori R, Scopinaro F, Bagni O. Absorbed dose to lesion and clinical outcome after liver radioembolization with 90Y microspheres: a case report of PET-based dosimetry. Ann Nucl Med. 2013 Aug;27(7):676-80. doi: 10.1007/s12149-013-0726-4. Epub 2013 Apr 20.
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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. This study is not recruiting at the moment.
Mark P Supanich, Ph.D. principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Rush University Medical 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 2 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: withdrawn, as of the sponsor's last update on 8 Oct 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correlation of CT perfusion metrics to radiation dose deposition of Y-90 as measured by PET/CT (time frame: 1 year). 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 NCT02558205, which also lists 5 linked publications.
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 8 Oct 2020.