CancerNCT02249520
Calibration of MR and PET-MR Imaging Protocols at RIC
A study testing PET-MR imaging on Biograph mMR scanner, MR-only imaging on Biograph mMR scanner and MR imaging on the Siemens Vida 3T MR scanner in people with Cancer and Coronary Artery Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This is a protocol to facilitate on-site calibration of the technical aspects of the Siemens Biograph mMR (molecular MR) Positron Emission Tomography-Magnetic Resonance (PET-MR) scanner and the 3T Siemens Vida MR scanner at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging Research Institute (BIRI) Research… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Coronary Artery Disease
- What is being tested?
- PET-MR imaging on Biograph mMR scanner, MR-only imaging on Biograph mMR scanner and MR imaging on the Siemens Vida 3T MR scanner
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2040
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- For MR-PET calibration: Outpatient undergoing standard-of-care 18FDG-PET at S. Mark Taper Foundation Imaging Center at CSMC
- For MR-only calibration: Volunteers who are responding to approved advertising to volunteer at the BIRI Research Imaging Core for research MR
Who cannot join
- Age < 18 years
- Pregnancy
- Any contraindications to MR imaging.
- Any contraindication to MRI, including metallic implants (valve replacement, pacemaker, implantable cardiac defibrillator, metallic spine material), intracranial clips, metallic fragments in eyes, and claustrophobia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Calibration of MR and PET-MR Imaging Protocols at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging Research Institute (BIRI) Research Imaging Core
This is a protocol to facilitate on-site calibration of the technical aspects of the Siemens Biograph mMR (molecular MR) Positron Emission Tomography-Magnetic Resonance (PET-MR) scanner and the 3T Siemens Vida MR scanner at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging Research Institute (BIRI) Research Imaging Core after scanner installation. The mMR is a FDA-approved standard clinical device (non-experimental) and will be used in accordance with clearance and approval from the FDA. The Vida is a state-of-the-art FDA approved scanner and will be clinically licensed within a short time.
Read the detailed description
PET-MR Protocol on the Biograph mMR: This protocol requires the use of a radioisotope. To avoid administering radioisotope solely for the purposes of this calibration, we will recruit 20 patients from the clinical population at the S. Mark Taper Foundation Imaging Center at CSMC who are already receiving an isotope dose for their standard-of-care examination and are willing to be scanned at the Research Imaging Core on the same day right after their clinical exam. Subjects who are having a PET-MR after receiving FDG will have the same body part scanned as they did for clinical testing.
MR-only Protocol on the Biograph mMR:To set up MR-only protocols, we will enroll 20 volunteers for MR-only on the mMR scanner. This is a standard MR scan with no isotope involved. Those volunteers who are participating in the MR-only scan will have major body parts and organs scanned as needed for calibration.
MR imaging on the Siemens Vida 3T scanner: applications training is taking place and we will build clinical protocols in the future
- Conditions
- Cancer, Coronary Artery Disease
- Being tested
- PET-MR imaging on Biograph mMR scanner, MR-only imaging on Biograph mMR scanner, MR imaging on the Siemens Vida 3T MR scanner
- Keywords
- Magnetic Resonance Imaging, MRI, Positron Emission Tomography, PET, PET-MR, mMR
- Medical subject headings
- Neoplasms, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MR imaging on Biograph mMR scannerOther
Also called Siemens Biograph mMR, molecular imaging, PET-MR, mMR
Participants will undergo PET-MR imaging on the Biograph mMR scanner to evaluate the technical aspects of the total acquisition protocol directly post clinical administration of FDG, thus removing the requirement for additional radioisotope.
MR-only imaging on Biograph mMR scannerOther
Also called Siemens Biograph mMR, PET-MR
Participants will undergo MR-only imaging to test the technical aspects of the MR-only protocol on the Biograph mMR scanner. No drug administered.
MR imaging on the Siemens Vida 3T MR scannerOther
Also called MRI
Participants will undergo MR imaging to test the technical aspects of the MR protocol on the Vida MR scanner
| Study group | Role | What they receive |
|---|---|---|
| PET-MR imaging on Biograph mMR scanner | Other | Research PET-MR imaging on Biograph mMR scanner will be conducted immediately following administration of FDG for clinically approved scan. No additional radioisotope will be administered for the research scan. Receives: Other: PET-MR imaging on Biograph mMR scanner |
| MR-only imaging on Biograph mMR scanner | Other | Participants will undergo research MR-only imaging on Biograph mMR scanner. Receives: Other: MR-only imaging on Biograph mMR scanner |
| MR imaging on the Siemens Vida 3T MR scanner | Other | Participants will undergo research MR imaging on the Siemens MR scanner Receives: Other: MR imaging on the Siemens Vida 3T MR scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of measures of organ uptake, maximum target-to-background ratio and maximum standard uptake value as standard with FDG PET for maximum image quality for all standard protocols.
The mMR is a FDA-approved standard clinical device (non-experimental) and will be used in accordance with clearance and approval from the FDA. Results obtained from these tests will not be analyzed towards the end point of any study and will solely be used to finalize and calibrate the technical performance of the new scanner. All scans will be visually assessed for technique calibration.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (estimated)
Why it stopped: Unable to enroll patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel S. Berman, Cedars-Sinai Medical Center
- Investigators
- Daniel S. Berman, M.D., Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249520
- Sponsor's protocol ID
- 35521
- Status last verified
- Aug 2024
- First submitted
- 9 Sep 2014
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration of MR and PET-MR Imaging Protocols at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging Research Institute (BIRI) Research Imaging Core
- ClinicalTrials.gov ID
- NCT02249520
- Acronym / sponsor ID
- 35521
- Conditions
- Cancer, Coronary Artery Disease
- Keywords
- Magnetic Resonance Imaging, MRI, Positron Emission Tomography, PET, PET-MR, mMR
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 25 Sep 2014 (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.
This is a protocol to facilitate on-site calibration of the technical aspects of the Siemens Biograph mMR (molecular MR) Positron Emission Tomography-Magnetic Resonance (PET-MR) scanner and the 3T Siemens Vida MR scanner at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging Research Institute (BIRI) Research Imaging Core after scanner installation. The mMR is a FDA-approved standard clinical device (non-experimental) and will be used in accordance with clearance and approval from the FDA. The Vida is a state-of-the-art FDA approved scanner and will be clinically licensed within a short time.
Detailed description
PET-MR Protocol on the Biograph mMR: This protocol requires the use of a radioisotope. To avoid administering radioisotope solely for the purposes of this calibration, we will recruit 20 patients from the clinical population at the S. Mark Taper Foundation Imaging Center at CSMC who are already receiving an isotope dose for their standard-of-care examination and are willing to be scanned at the Research Imaging Core on the same day right after their clinical exam. Subjects who are having a PET-MR after receiving FDG will have the same body part scanned as they did for clinical testing.
MR-only Protocol on the Biograph mMR:To set up MR-only protocols, we will enroll 20 volunteers for MR-only on the mMR scanner. This is a standard MR scan with no isotope involved. Those volunteers who are participating in the MR-only scan will have major body parts and organs scanned as needed for calibration.
MR imaging on the Siemens Vida 3T scanner: applications training is taking place and we will build clinical protocols in the future
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PET-MR imaging on Biograph mMR scanner | Other | Other: PET-MR imaging on Biograph mMR scannerResearch PET-MR imaging on Biograph mMR scanner will be conducted immediately following administration of FDG for clinically approved scan. No additional radioisotope will be administered for the research scan. |
| MR-only imaging on Biograph mMR scanner | Other | Other: MR-only imaging on Biograph mMR scannerParticipants will undergo research MR-only imaging on Biograph mMR scanner. |
| MR imaging on the Siemens Vida 3T MR scanner | Other | Other: MR imaging on the Siemens Vida 3T MR scannerParticipants will undergo research MR imaging on the Siemens MR scanner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years.
- For MR-PET calibration: Outpatient undergoing standard-of-care 18FDG-PET at S. Mark Taper Foundation Imaging Center at CSMC
- For MR-only calibration: Volunteers who are responding to approved advertising to volunteer at the BIRI Research Imaging Core for research MR
Key exclusion criteria (4 listed)
- Age < 18 years
- Pregnancy
- Any contraindications to MR imaging.
- Any contraindication to MRI, including metallic implants (valve replacement, pacemaker, implantable cardiac defibrillator, metallic spine material), intracranial clips, metallic fragments in eyes, and claustrophobia.
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-MR imaging on Biograph mMR scannerAlso: Siemens Biograph mMR, molecular imaging, PET-MR, mMRParticipants will undergo PET-MR imaging on the Biograph mMR scanner to evaluate the technical aspects of the total acquisition protocol directly post clinical administration of FDG, thus removing the requirement for additional radioisotope. | Other | PET-MR imaging on Biograph mMR scanner |
| MR-only imaging on Biograph mMR scannerAlso: Siemens Biograph mMR, PET-MRParticipants will undergo MR-only imaging to test the technical aspects of the MR-only protocol on the Biograph mMR scanner. No drug administered. | Other | MR-only imaging on Biograph mMR scanner |
| MR imaging on the Siemens Vida 3T MR scannerAlso: MRIParticipants will undergo MR imaging to test the technical aspects of the MR protocol on the Vida MR scanner | Other | MR imaging on the Siemens Vida 3T MR scanner |
Primary outcome
composite of measures of organ uptake, maximum target-to-background ratio and maximum standard uptake value as standard with FDG PET for maximum image quality for all standard protocols.
Time frame: one day
The mMR is a FDA-approved standard clinical device (non-experimental) and will be used in accordance with clearance and approval from the FDA. Results obtained from these tests will not be analyzed towards the end point of any study and will solely be used to finalize and calibrate the technical performance of the new scanner. All scans will be visually assessed for technique calibration.
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 21 Aug 2024.
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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.
Daniel S. Berman, M.D. principal investigator
Cedars-Sinai Medical 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-MR imaging on Biograph mMR scanner, MR-only imaging on Biograph mMR scanner and MR imaging on the Siemens Vida 3T MR scanner in people with Cancer and Coronary Artery Disease, run by Cedars-Sinai 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 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: withdrawn, as of the sponsor's last update on 21 Aug 2024. 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?
composite of measures of organ uptake, maximum target-to-background ratio and maximum standard uptake value as standard with FDG PET for maximum image quality for all standard protocols. (time frame: one day). 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 21 Aug 2024.