Prostate CancerNCT02106416
Use of PET/MRI Tracer to Further Understanding of Prostate Cancer Development
A study testing PET/MRI in people with Prostate Cancer and Bladder Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to develop a novel technique for integrated PET/MRI tracer kinetic analysis for urologic malignancy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Bladder Cancer
- What is being tested?
- PET/MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Apr 2016
- 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
- The study population will consist of patients with known urologic cancer who are scheduled to undergo MRI with gadolinium for their routine care. Patients will be referred by the Urology or Medical Oncology Departments for participation in the study. Subjects will be selected on the basis of their willingness and ability to participate and on their likelihood of completing the study. Patients agreeing to participate will be presented with a flyer which will inform subject about the available research study and study contact information. participation is entirely voluntary, and a subject may withdraw from the study at any time. Normal volunteers will be recruited accessing the existing database of normal volunteers maintained in Radiology Research department.
Who cannot join
- Normal MRI exclusion criteria will apply, including those on the following list. A standard MRI safety form will be used to identify potential conditions warranting exclusion.
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
- Ferromagnetic objects such as jewelry or metal clips in clothing
- Claustrophobia
- History of seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: Development of a Novel Technique for PET/MRI Tracer Kinetic Analysis for Urologic Pelvic Malignancy
The purpose of this study is to develop a novel technique for integrated PET/MRI tracer kinetic analysis for urologic malignancy.
Read the detailed description
Patients scheduled to undergo gadolinium-enhanced MRI for urologic malignancy will be recruited to undergo PET/MRI employing simultaneous dynamic acquisition of PET and gadolinium-chelate data sets. For initial technical development within this pilot study, analysis will be performed attempting to compute tracer delivery using inputs from an integrated MRI-perfusion analysis. Flow and permeability will be obtained from the MR perfusion analysis, which can be used to compute the inflow rate constant K1. K1, reflecting the transfer of contrast, will then be used to compute the metabolic uptake of FDG by the organ as well as of any visible tumors. A determination will be made whether this metabolic uptake is successfully computed for each case. If not, then acquisition and post-processing modifications will be made for subsequent cases.
- Conditions
- Prostate Cancer, Bladder Cancer
- Being tested
- PET/MRI
- Keywords
- prostate cancer, bladder cancer, MRI, PET, perfusion
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIProcedure or surgery
Also called Siemens Biograph mMR
Simultaneous PET/MRI (3T system)
| Study group | Role | What they receive |
|---|---|---|
| PET/MRI | Experimental | Patient receives PET/MRI Receives: Procedure: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The inflow rate constant K1
The inflow rate constant K1 will be calculated based on assessment of dynamic PET/MRI data.
Measured: Within six months of scan completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startAug 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Rosenkrantz, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106416
- Sponsor's protocol ID
- 13-00394
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2013
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Technique for PET/MRI Tracer Kinetic Analysis for Urologic Pelvic Malignancy
- ClinicalTrials.gov ID
- NCT02106416
- Acronym / sponsor ID
- 13-00394
- Conditions
- Prostate Cancer, Bladder Cancer
- Keywords
- prostate cancer, bladder cancer, MRI, PET, perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Apr 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.
The purpose of this study is to develop a novel technique for integrated PET/MRI tracer kinetic analysis for urologic malignancy.
Detailed description
Patients scheduled to undergo gadolinium-enhanced MRI for urologic malignancy will be recruited to undergo PET/MRI employing simultaneous dynamic acquisition of PET and gadolinium-chelate data sets. For initial technical development within this pilot study, analysis will be performed attempting to compute tracer delivery using inputs from an integrated MRI-perfusion analysis. Flow and permeability will be obtained from the MR perfusion analysis, which can be used to compute the inflow rate constant K1. K1, reflecting the transfer of contrast, will then be used to compute the metabolic uptake of FDG by the organ as well as of any visible tumors. A determination will be made whether this metabolic uptake is successfully computed for each case. If not, then acquisition and post-processing modifications will be made for subsequent cases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/MRI | Experimental | Procedure: PET/MRIPatient receives PET/MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study population will consist of patients with known urologic cancer who are scheduled to undergo MRI with gadolinium for their routine care. Patients will be referred by the Urology or Medical Oncology Departments for participation in the study. Subjects will be selected on the basis of their willingness and ability to participate and on their likelihood of completing the study. Patients agreeing to participate will be presented with a flyer which will inform subject about the available research study and study contact information. participation is entirely voluntary, and a subject may withdraw from the study at any time. Normal volunteers will be recruited accessing the existing database of normal volunteers maintained in Radiology Research department.
Key exclusion criteria (6 listed)
- Normal MRI exclusion criteria will apply, including those on the following list. A standard MRI safety form will be used to identify potential conditions warranting exclusion.
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
- Ferromagnetic objects such as jewelry or metal clips in clothing
- 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/MRIAlso: Siemens Biograph mMRSimultaneous PET/MRI (3T system) | Procedure or surgery | PET/MRI |
Primary outcome
The inflow rate constant K1
Time frame: Within six months of scan completion
The inflow rate constant K1 will be calculated based on assessment of dynamic PET/MRI data.
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 11 Oct 2017.
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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.
Andrew Rosenkrantz, MD principal investigator
NYU School of Medicine
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/MRI in people with Prostate Cancer and Bladder Cancer, run by NYU Langone Health 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 1 inclusion and 6 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 11 Oct 2017. 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?
The inflow rate constant K1 (time frame: Within six months of scan completion). 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 11 Oct 2017.