Head and Neck CancerNCT01535898
Application of High Resolution Diffusion-weighted MR Imaging Pulse Sequence in Head and Neck, and Prostate Cancers
An observational study of Head and Neck Cancer and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if a new MR imaging method can help tumor evaluation in head and neck cancer or prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer, Prostate Cancer
- What is being tested?
- MRI scanner with sequence
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Feb 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The radiologists on the study will identify potential research participants from those patients who are scheduled for MRI examination as part of their routine clinical care.
Who may be able to join
- Adults aged 18 and over.
- Men and women without regard to ethnic background.
- Patients/Subjects able to give informed consent
- Patients/Subjects whose weight does not exceed 275 lbs.
- Patient with a known or suspected head and neck cancer or prostate cancer scheduled for an MRI scan as part of their routine care --OR--
- Volunteer with no history of the disease in that category.
Who cannot join
- Patients who are unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if a new MR imaging method can help tumor evaluation in head and neck cancer or prostate cancer. The extra images will be obtained using Diffusion-weighted Magnetic Resonance Imaging which provides image contrast through detection of small restrictions in the movement of water molecules. This study may help us provide additional information about the tumor along with the picture of the organ.
- Conditions
- Head and Neck Cancer, Prostate Cancer
- Being tested
- MRI scanner with sequence
- Keywords
- MRI, MR imaging Pulse Sequence, High Resolution Diffusion-weighted, Questionnaire, 12-033
- Medical subject headings
- Head and Neck Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanner with sequenceOther
The intervention for the patients is the additional 10 minutes in the MRI scanner with sequence. The intervention for the volunteers is the scan, which will take a total of 30 minutes. The volunteers will have two more additional studies at 1-2 week intervals. Both the patients and volunteers will also need to fill out a questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Pts having an MRI | This is a technology assessment protocol. The study is designed to assess the utility of the technology using a limited number of participants. Receives: Other: MRI scanner with sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of high resolution diffusion-weighted imaging
using a new DWI pulse sequence from the manufacturer (General Electric Medical Systems (Milwaukee, WI)) for the assessment of head and neck cancer cancer and prostate cancer.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amita Dave, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535898
- Sponsor's protocol ID
- 12-033
- Status last verified
- May 2017
- First submitted
- 13 Feb 2012
- Last updated
- 8 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of High Resolution Diffusion-weighted MR Imaging Pulse Sequence in Head and Neck, and Prostate Cancers
- ClinicalTrials.gov ID
- NCT01535898
- Acronym / sponsor ID
- 12-033
- Conditions
- Head and Neck Cancer, Prostate Cancer
- Keywords
- MRI, MR imaging Pulse Sequence, High Resolution Diffusion-weighted, Questionnaire, 12-033
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 Feb 2012 (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.
Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if a new MR imaging method can help tumor evaluation in head and neck cancer or prostate cancer. The extra images will be obtained using Diffusion-weighted Magnetic Resonance Imaging which provides image contrast through detection of small restrictions in the movement of water molecules. This study may help us provide additional information about the tumor along with the picture of the organ.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pts having an MRI | – | Other: MRI scanner with sequenceThis is a technology assessment protocol. The study is designed to assess the utility of the technology using a limited number of participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The radiologists on the study will identify potential research participants from those patients who are scheduled for MRI examination as part of their routine clinical care.
Key inclusion criteria (6 listed)
- Adults aged 18 and over.
- Men and women without regard to ethnic background.
- Patients/Subjects able to give informed consent
- Patients/Subjects whose weight does not exceed 275 lbs.
- Patient with a known or suspected head and neck cancer or prostate cancer scheduled for an MRI scan as part of their routine care --OR--
Key exclusion criteria (1 listed)
- Patients who are unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.
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 |
|---|---|---|
| MRI scanner with sequenceThe intervention for the patients is the additional 10 minutes in the MRI scanner with sequence. The intervention for the volunteers is the scan, which will take a total of 30 minutes. The volunteers will have two more additional studies at 1-2 week intervals. Both the patients and volunteers will also need to fill out a questionnaire. | Other | Pts having an MRI |
Primary outcome
feasibility of high resolution diffusion-weighted imaging
Time frame: 2 years
using a new DWI pulse sequence from the manufacturer (General Electric Medical Systems (Milwaukee, WI)) for the assessment of head and neck cancer cancer and prostate cancer.
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 8 May 2017.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Amita Dave, PhD principal investigator
Memorial Sloan Kettering 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 Head and Neck Cancer and Prostate Cancer, run by Memorial Sloan Kettering 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 6 inclusion and 1 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 8 May 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?
feasibility of high resolution diffusion-weighted imaging (time frame: 2 years). 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 8 May 2017.