Hepatic MalignanciesNCT04332419
Comparison of Yttrium-90 Absorbed Doses Using PET/CT Versus PET/MR Imaging for Hepatic Malignancies
A study testing PET/CT, PET/MR and SIRT with Y-90 in people with Hepatic Malignancies, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the results of positron emission tomography/computer tomography (PET/CT) to positron emission tomography/magnetic resonance imaging (PET/MRI) to help determine any added advantage of one over the other in relation to a tumor which might assist in further management plans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Malignancies
- What is being tested?
- PET/CT, PET/MR and SIRT with Y-90
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2020to 21 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The patient has a liver malignancy and is scheduled for SIRT with Y-90; AND
- The patient is an adult, self-competent, and able to provide informed consent to participate in the study
Who cannot join
- The patient loses competence, has a condition that questions their ability to provide informed consent independently (e.g. cannot communicate in English), or withdraws consent to participate within any time in the study period; OR
- The patient is not eligible to undergo MRI due to the presence of metal devices or implants in their body; OR
- Both imaging modalities cannot take place within 6 hours after Y-90 RE; OR
- Both imaging modalities cannot take place within 1 hour apart from each other
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44122
About this study
Official title: Comparison of Yttrium-90 Absorbed Doses Using PET/CT Versus PET/MR Imaging in Patients Undergoing Selective Internal Radiation Therapy for Hepatic Malignancies
The purpose of this study is to compare the results of positron emission tomography/computer tomography (PET/CT) to positron emission tomography/magnetic resonance imaging (PET/MRI) to help determine any added advantage of one over the other in relation to a tumor which might assist in further management plans.
Read the detailed description
Participants in this study will undergo PET/CT (standard imaging) and PET/MR (additional imaging), within 6 hours after SIRT with Y-90 for palliative treatment of the liver malignancy. Patients will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart. Upon acquirement and construction of PET/CT and PET/MR images, a software (MIM SurePlan LiverY90) would be utilized for semi-automatic determination of the liver/tumor contours and calculation of the Y-90 absorbed doses (Gy) in the regions of interest (including within tumor and background liver outlines) using the Local Deposition Method.
The primary objective of this study is to assess the agreement between post-Y-90 RE absorbed doses (Gy) in the liver tumor tissues based on PET/CT versus PET/MR imaging. This would permit the comparison of Y-90 tumor absorbed doses, acquired from PET/MR, with the current standard of care PET/CT imaging to verify the data consistency and to validate its application for the prediction of tumor response to treatment.
The secondary objective of this study is to assess the agreement between post-Y-90 RE absorbed doses (Gy) in the background liver tissues (surrounding tumors), based on PET/CT versus PET/MR imaging. This would permit the comparison of Y-90 background liver absorbed doses, acquired from PET/MR, with the current standard of care PET/CT imaging to verify the data consistency and to validate its application for the prediction of dose toxicity.
- Conditions
- Hepatic Malignancies
- Being tested
- PET/CT, PET/MR, SIRT with Y-90
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDevice
Standard Imaging
PET/MRDevice
Additional Imaging
SIRT with Y-90Radiation
SIRT with Y-90 for palliative treatment of the liver malignancy.
| Study group | Role | What they receive |
|---|---|---|
| PET/CT & PET/MR | Experimental | One-time PET/MR imaging in addition to the standard PET/CT imaging, both performed on the same day of the treatment procedure (Selective Internal Radiation Therapy Y-90 RE). Participants will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart. Receives: Device: PET/CT; Device: PET/MR; Radiation: SIRT with Y-90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility Coefficient (RDC) Between the Two Imaging Modalities in Liver Tumor Tissues
RDC between the two imaging modalities for post-Y-90 Radioembolization (RE) absorbed doses (Gy) in the liver tumor tissues The RDC is the minimum difference between the two measurements that can be considered a true difference, with 95% confidence.
Measured: Post-op day 0, 1 hour apart
Secondary outcomes (1)
RDC Between the Two Imaging Modalities in Background Liver Tissues
RDC between the two imaging modalities for post-Y-90 RE absorbed doses (Gy) in the background liver tissues
The RDC is the minimum difference between the two measurements that can be considered a true difference, with 95% confidence.
Measured: Post-op day 0, 1 hour apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start3 Mar 2020
- Primary completion21 Sep 2020
- Study completion21 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatic MalignanciesStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ram Gurajala, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332419
- Sponsor's protocol ID
- CASE13219
- Status last verified
- Jun 2022
- First submitted
- 31 Mar 2020
- Last updated
- 22 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Team will be sharing study results but not IPD because of HIPAA regulations
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Yttrium-90 Absorbed Doses Using PET/CT Versus PET/MR Imaging in Patients Undergoing Selective Internal Radiation Therapy for Hepatic Malignancies
- ClinicalTrials.gov ID
- NCT04332419
- Acronym / sponsor ID
- CASE13219
- Conditions
- Hepatic Malignancies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Posted 5 Oct 2021
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 compare the results of positron emission tomography/computer tomography (PET/CT) to positron emission tomography/magnetic resonance imaging (PET/MRI) to help determine any added advantage of one over the other in relation to a tumor which might assist in further management plans.
Detailed description
Participants in this study will undergo PET/CT (standard imaging) and PET/MR (additional imaging), within 6 hours after SIRT with Y-90 for palliative treatment of the liver malignancy. Patients will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart. Upon acquirement and construction of PET/CT and PET/MR images, a software (MIM SurePlan LiverY90) would be utilized for semi-automatic determination of the liver/tumor contours and calculation of the Y-90 absorbed doses (Gy) in the regions of interest (including within tumor and background liver outlines) using the Local Deposition Method.
The primary objective of this study is to assess the agreement between post-Y-90 RE absorbed doses (Gy) in the liver tumor tissues based on PET/CT versus PET/MR imaging. This would permit the comparison of Y-90 tumor absorbed doses, acquired from PET/MR, with the current standard of care PET/CT imaging to verify the data consistency and to validate its application for the prediction of tumor response to treatment.
The secondary objective of this study is to assess the agreement between post-Y-90 RE absorbed doses (Gy) in the background liver tissues (surrounding tumors), based on PET/CT versus PET/MR imaging. This would permit the comparison of Y-90 background liver absorbed doses, acquired from PET/MR, with the current standard of care PET/CT imaging to verify the data consistency and to validate its application for the prediction of dose toxicity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT & PET/MR | Experimental | Device: PET/CT, Device: PET/MR, Radiation: SIRT with Y-90One-time PET/MR imaging in addition to the standard PET/CT imaging, both performed on the same day of the treatment procedure (Selective Internal Radiation Therapy Y-90 RE). Participants will be randomized to receive either of the imaging modalities first, based on the availability of the imaging device, and less than 1 hour apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient has a liver malignancy and is scheduled for SIRT with Y-90; AND
- The patient is an adult, self-competent, and able to provide informed consent to participate in the study
Key exclusion criteria (4 listed)
- The patient loses competence, has a condition that questions their ability to provide informed consent independently (e.g. cannot communicate in English), or withdraws consent to participate within any time in the study period; OR
- The patient is not eligible to undergo MRI due to the presence of metal devices or implants in their body; OR
- Both imaging modalities cannot take place within 6 hours after Y-90 RE; OR
- Both imaging modalities cannot take place within 1 hour apart from each other
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 |
|---|---|---|
| PET/CTStandard Imaging | Device | PET/CT & PET/MR |
| PET/MRAdditional Imaging | Device | PET/CT & PET/MR |
| SIRT with Y-90SIRT with Y-90 for palliative treatment of the liver malignancy. | Radiation | PET/CT & PET/MR |
Primary outcome
Reproducibility Coefficient (RDC) Between the Two Imaging Modalities in Liver Tumor Tissues
Time frame: Post-op day 0, 1 hour apart
RDC between the two imaging modalities for post-Y-90 Radioembolization (RE) absorbed doses (Gy) in the liver tumor tissues The RDC is the minimum difference between the two measurements that can be considered a true difference, with 95% confidence.
1 secondary outcome
RDC Between the Two Imaging Modalities in Background Liver Tissues
Time frame: Post-op day 0, 1 hour apart
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Team will be sharing study results but not IPD because of HIPAA regulations
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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.
Ram Gurajala, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT, PET/MR and SIRT with Y-90 in people with Hepatic Malignancies, run by Case Comprehensive 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 2 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: finished, as of the sponsor's last update on 22 Jun 2022. 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?
Yes. Results are posted in the registry (first posted 5 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reproducibility Coefficient (RDC) Between the Two Imaging Modalities in Liver Tumor Tissues (time frame: Post-op day 0, 1 hour apart). 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 22 Jun 2022.