Positron Emission Tomography-Magnetic Resonance (PET-MR)NCT03603925
Enhancing SUV Accuracy of PET/MR for Clinical Trial Qualification
An observational study of Positron Emission Tomography-Magnetic Resonance (PET-MR), run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
Standardized Uptake Values (SUVs), normalized activity concentration, measured using PET/MR have inaccuracies ≥ 20% which exceeds National Cancer Institute / American College of Radiology Imaging Network (NCI/ACRIN), Radiological Society of North America / Quantitative Imaging Biomarkers Alliance (RSNA/QIBA)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Positron Emission Tomography-Magnetic Resonance (PET-MR)
- What is being tested?
- Positron Emission Test / Magnetic Resonance (PET/MR) and Positron Emission Test / Computed Tomography (PET/CT)
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 7 Apr 2021
- 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 receiving PET/CT at University Hospitals Cleveland Medical Center (UHCMC) for a clinical indication
Who may be able to join
- Receiving PET/CT at University Hospitals Cleveland Medical Center (UHCMC) for a clinical indication
- No Contraindications to undergo MR as assessed using University Hospitals (UH) Radiology standard MR assessment form
- Has the ability to understand and willingness to sign a written informed consent
- The circumference of the volunteer in the body section, as determined using a measuring tape, to be scanned must be less than or equal to 110 cm to avoid field of view limitations on the PET/MR
Who cannot join
- Patient size or circumference greater than the MR gantry of the PET/MR.
- Pregnancy or lactation.
- Contraindications to undergo MR as assessed using UH Radiology standard MR assessment form.
- Claustrophobia or inability to tolerate MR examination (lay still for approximately 1 hour and hold breath intermittently).
- Individuals who are not willing or capable of giving informed consent or assent (with legal guardian consent).
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Standardized Uptake Values (SUVs), normalized activity concentration, measured using PET/MR have inaccuracies ≥ 20% which exceeds National Cancer Institute / American College of Radiology Imaging Network (NCI/ACRIN), Radiological Society of North America / Quantitative Imaging Biomarkers Alliance (RSNA/QIBA) specifications and disqualifies PET/MR from multicenter or cooperative group clinical trials. High inaccuracy is primarily due to poor attenuation correction (AC) owing to lack of computed tomography (CT) data. This study will develop acquisition and analyses methods to synthesize CT images from MR data that can be used to achieve SUVs that are within 5% of those obtained using PET/CT (reference standard), thus meeting accuracy requirements needed to qualify for multicenter trials.
The overall goal of this research project is to validate clinically practical methods for producing MR-based attenuation correction information which is needed to produce quantitatively accurate PET images from a PET/MR scanner. Existing commercial PET/MR systems use methods that are inaccurate.
Read the detailed description
Objective The primary objective is to demonstrate that, using the new acquisition and analysis methods for MR-AC, PET SUVs in lesions and normal tissues can be measured using PET/MR and be within 5% agreement of those measured using PET/CT.
The secondary objective is to demonstrate visual and quantitative agreement between synthesized CT images generated from MR data and the reference, measured CT images.
Study Design This study would like to enroll patients receiving a clinically indicated PET/CT scan. The patients will be asked to agree to a receive research PET/MR scan within the study which requires additional time and potential MR risks for the patient. It does not entail extra injections or radiation exposure. Research acquisition and processing will be performed on the PET/MR data to create PET images that are expected to have quantitatively accurate SUVs. These will be compared to SUVs from the clinical PET/CT which will serve as the reference standard.
Outcome By bringing together cutting-edge advances in both MR acquisition and image analyses, the successful completion of these aims will achieve SUVs that are within 5% of those obtained with PET/CT (reference standard) with clinically appropriate acquisition time, image quality, and diagnostic accuracy, so that PET/MR systems meet SUV accuracy requirements needed to qualify for cooperative group clinical trials.
- Being tested
- Positron Emission Test / Magnetic Resonance (PET/MR), Positron Emission Test / Computed Tomography (PET/CT)
- Keywords
- Computed tomography, standardized update values
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission Test / Magnetic Resonance (PET/MR)Diagnostic test
The Philips Ingenuity PET/MR is used for research scanning. Patients receiving a clinically indicated PET/CT, will be approached to be included in this study. There is no special preparation other than that needed for the prerequisite PET/CT scanning. At the completion of the PET/CT scanning, the subject will be taken to the PET/MR scanner, which is in close in proximity, for research scanning. The research scanning would take up to one hour or as tolerated.
Positron Emission Test / Computed Tomography (PET/CT)Diagnostic test
Patients will receive PET / CT imaging for the detection of cancer or other clinically indicated anomalies. The completed study visit is expected to take approximately 2 hours and not longer than 3 hours.
| Study group | Role | What they receive |
|---|---|---|
| PET/MR + PET/CT | The interventions for participating in this research are centered around steps needed to safely and ethically collect a research PET/MR scan following a standard-of-care PET/CT scan. The patient will be imaged in at least one of several standard anatomic areas: head/neck, thorax, abdomen, pelvis or whole-body. Receives: Diagnostic Test: Positron Emission Test / Magnetic Resonance (PET/MR); Diagnostic Test: Positron Emission Test / Computed Tomography (PET/CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative agreement between measured CT and CT synthesized from MR data (Hounsfield Units)
Demonstrate quantitative agreement between measured CT and CT synthesized from MR data
Measured: Up to 3 hours after beginning scan
Quantitative agreement in the derived linear attenuation coefficients at 511 kilo electro volts (keV).
Demonstrate quantitative agreement in the derived linear attenuation coefficients at 511 keV.
Measured: Up to 3 hours after beginning scan
Secondary outcomes (1)
Percent difference in Standardized Uptake Values (SUVs) in PET/CT scans compared to PET/MR scans
Demonstrate that SUVs in lesions and normal tissues measured using MR-based attenuation correction (MR-AC) are within 5% of those measured using PET/CT.
Measured: Up to 3 hours after beginning scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start17 Jun 2019
- Primary completion7 Apr 2021
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positron Emission Tomography-Magnetic Resonance (PET-MR)Studies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Raymond F. Muzic, PhD, Principal investigator, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603925
- Sponsor's protocol ID
- CASE3Y18
- Other IDs
- R01CA196687
- Status last verified
- Oct 2021
- First submitted
- 19 Jul 2018
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing SUV Accuracy of PET/MR for Clinical Trial Qualification
- ClinicalTrials.gov ID
- NCT03603925
- Acronym / sponsor ID
- CASE3Y18
- Keywords
- Computed tomography, standardized update values
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 27 Jul 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.
Standardized Uptake Values (SUVs), normalized activity concentration, measured using PET/MR have inaccuracies ≥ 20% which exceeds National Cancer Institute / American College of Radiology Imaging Network (NCI/ACRIN), Radiological Society of North America / Quantitative Imaging Biomarkers Alliance (RSNA/QIBA) specifications and disqualifies PET/MR from multicenter or cooperative group clinical trials. High inaccuracy is primarily due to poor attenuation correction (AC) owing to lack of computed tomography (CT) data. This study will develop acquisition and analyses methods to synthesize CT images from MR data that can be used to achieve SUVs that are within 5% of those obtained using PET/CT (reference standard), thus meeting accuracy requirements needed to qualify for multicenter trials.
The overall goal of this research project is to validate clinically practical methods for producing MR-based attenuation correction information which is needed to produce quantitatively accurate PET images from a PET/MR scanner. Existing commercial PET/MR systems use methods that are inaccurate.
Detailed description
Objective The primary objective is to demonstrate that, using the new acquisition and analysis methods for MR-AC, PET SUVs in lesions and normal tissues can be measured using PET/MR and be within 5% agreement of those measured using PET/CT.
The secondary objective is to demonstrate visual and quantitative agreement between synthesized CT images generated from MR data and the reference, measured CT images.
Study Design This study would like to enroll patients receiving a clinically indicated PET/CT scan. The patients will be asked to agree to a receive research PET/MR scan within the study which requires additional time and potential MR risks for the patient. It does not entail extra injections or radiation exposure. Research acquisition and processing will be performed on the PET/MR data to create PET images that are expected to have quantitatively accurate SUVs. These will be compared to SUVs from the clinical PET/CT which will serve as the reference standard.
Outcome By bringing together cutting-edge advances in both MR acquisition and image analyses, the successful completion of these aims will achieve SUVs that are within 5% of those obtained with PET/CT (reference standard) with clinically appropriate acquisition time, image quality, and diagnostic accuracy, so that PET/MR systems meet SUV accuracy requirements needed to qualify for cooperative group clinical trials.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/MR + PET/CT | – | Diagnostic Test: Positron Emission Test / Magnetic Resonance (PET/MR), Diagnostic Test: Positron Emission Test / Computed Tomography (PET/CT)The interventions for participating in this research are centered around steps needed to safely and ethically collect a research PET/MR scan following a standard-of-care PET/CT scan. The patient will be imaged in at least one of several standard anatomic areas: head/neck, thorax, abdomen, pelvis or whole-body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving PET/CT at University Hospitals Cleveland Medical Center (UHCMC) for a clinical indication
Key inclusion criteria (4 listed)
- Receiving PET/CT at University Hospitals Cleveland Medical Center (UHCMC) for a clinical indication
- No Contraindications to undergo MR as assessed using University Hospitals (UH) Radiology standard MR assessment form
- Has the ability to understand and willingness to sign a written informed consent
- The circumference of the volunteer in the body section, as determined using a measuring tape, to be scanned must be less than or equal to 110 cm to avoid field of view limitations on the PET/MR
Key exclusion criteria (5 listed)
- Patient size or circumference greater than the MR gantry of the PET/MR.
- Pregnancy or lactation.
- Contraindications to undergo MR as assessed using UH Radiology standard MR assessment form.
- Claustrophobia or inability to tolerate MR examination (lay still for approximately 1 hour and hold breath intermittently).
- Individuals who are not willing or capable of giving informed consent or assent (with legal guardian consent).
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 |
|---|---|---|
| Positron Emission Test / Magnetic Resonance (PET/MR)The Philips Ingenuity PET/MR is used for research scanning. Patients receiving a clinically indicated PET/CT, will be approached to be included in this study. There is no special preparation other than that needed for the prerequisite PET/CT scanning. At the completion of the PET/CT scanning, the subject will be taken to the PET/MR scanner, which is in close in proximity, for research scanning. The research scanning would take up to one hour or as tolerated. | Diagnostic test | PET/MR + PET/CT |
| Positron Emission Test / Computed Tomography (PET/CT)Patients will receive PET / CT imaging for the detection of cancer or other clinically indicated anomalies. The completed study visit is expected to take approximately 2 hours and not longer than 3 hours. | Diagnostic test | PET/MR + PET/CT |
Primary outcome
Quantitative agreement between measured CT and CT synthesized from MR data (Hounsfield Units)
Time frame: Up to 3 hours after beginning scan
Demonstrate quantitative agreement between measured CT and CT synthesized from MR data
Quantitative agreement in the derived linear attenuation coefficients at 511 kilo electro volts (keV).
Time frame: Up to 3 hours after beginning scan
Demonstrate quantitative agreement in the derived linear attenuation coefficients at 511 keV.
1 secondary outcome
Percent difference in Standardized Uptake Values (SUVs) in PET/CT scans compared to PET/MR scans
Time frame: Up to 3 hours after beginning scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
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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.
Raymond F. Muzic, PhD principal investigator
University Hospitals Seidman Cancer Center, 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?
An observational study of Positron Emission Tomography-Magnetic Resonance (PET-MR), 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 4 inclusion and 5 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 5 Nov 2021. 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?
Quantitative agreement between measured CT and CT synthesized from MR data (Hounsfield Units) (time frame: Up to 3 hours after beginning scan). 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?
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 5 Nov 2021.