Prostate CancerNCT02882958
Validation of Software-based Fusion of Ultrasound and MRI Images of the Prostate
An observational study of Prostate Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators hypothesize software-based fusion/navigation will be accurate to within 3 mm of the reference standard of EM fusion. The investigators aim to evaluate the accuracy of prostate US/MRI software-based fusion/navigation technology. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2018
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This will be single center study. Subjects will be recruited from those referred to interventional radiology for ultrasound-guided prostate fiducial placement, or those planing to undergo ultrasound-guided prostate fiducial placement in radiotherapy clinic.
Who may be able to join
- scheduled for ultrasound-guided gold seeds prostate fiducial placement prior to radiotherapy
Who cannot join
- eGFR < 45 mL/min/1.73m2
- recent (within 4 weeks) kidney or liver transplant
- contraindication to prostate MRI
- patient with cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize software-based fusion/navigation will be accurate to within 3 mm of the reference standard of EM fusion. The investigators aim to evaluate the accuracy of prostate US/MRI software-based fusion/navigation technology.
- Conditions
- Prostate Cancer
- Keywords
- Radiology
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Volume on Actual MRI
A post-procedure MRI performed within one month after the fiducial placement.
Measured: Within one month after the fiducial placement
Prostate Volume on US reconstruction
A US 3-D sweep will be performed during the fiducial placement.
Measured: During the fiducial placement
Prostate Volume based on US/EM reconstruction
A 3-D US sweep performed during the fiducial placement and a Electromagnetic tracking data will also be acquired at the same time, and then the two series of data will be used for US/EM reconstruction.
Measured: During the fiducial placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2018
- Study completionDec 2018
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 Massachusetts General HospitalThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Analogic Corporation
- Responsible party
- Principal investigator, Anthony Samir, Massachusetts General Hospital
- Investigators
- Anthony E. Samir, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882958
- Sponsor's protocol ID
- 2015P001681
- Status last verified
- Jan 2023
- First submitted
- 25 May 2016
- Last updated
- 6 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Software-based Fusion of Ultrasound and MRI Images of the Prostate
- ClinicalTrials.gov ID
- NCT02882958
- Acronym / sponsor ID
- 2015P001681
- Conditions
- Prostate Cancer
- Keywords
- Radiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Analogic Corporation
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Aug 2016 (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 investigators hypothesize software-based fusion/navigation will be accurate to within 3 mm of the reference standard of EM fusion. The investigators aim to evaluate the accuracy of prostate US/MRI software-based fusion/navigation technology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This will be single center study. Subjects will be recruited from those referred to interventional radiology for ultrasound-guided prostate fiducial placement, or those planing to undergo ultrasound-guided prostate fiducial placement in radiotherapy clinic.
Key inclusion criteria (1 listed)
- scheduled for ultrasound-guided gold seeds prostate fiducial placement prior to radiotherapy
Key exclusion criteria (4 listed)
- eGFR < 45 mL/min/1.73m2
- recent (within 4 weeks) kidney or liver transplant
- contraindication to prostate MRI
- patient with cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prostate Volume on Actual MRI
Time frame: Within one month after the fiducial placement
A post-procedure MRI performed within one month after the fiducial placement.
Prostate Volume on US reconstruction
Time frame: During the fiducial placement
A US 3-D sweep will be performed during the fiducial placement.
Prostate Volume based on US/EM reconstruction
Time frame: During the fiducial placement
A 3-D US sweep performed during the fiducial placement and a Electromagnetic tracking data will also be acquired at the same time, and then the two series of data will be used for US/EM reconstruction.
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 6 Jan 2023.
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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.
Anthony E. Samir, MD principal investigator
Massachusetts General Hospital
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 Prostate Cancer, run by Massachusetts General Hospital 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 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 6 Jan 2023. 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?
Prostate Volume on Actual MRI (time frame: Within one month after the fiducial placement). The study lists 3 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 6 Jan 2023.