CancerNCT02340715
Advanced MRI Sequences for Radiation Therapy Treatment Planning
An observational study of Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to determine if it would be helpful to use advanced MRI imaging techniques to take additional views of the tumor target for radiation treatment planning or treatment follow-up MRI. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cancer
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are planning to have radiation therapy for their cancer.
Who may be able to join
- Patients aged 18 years older of any race or gender with anal canal, brain, breast, cervix, esophagus, gynecology, head and neck, lung, pancreas, primary liver or liver metastases, prostate cancer or sarcoma either undergoing MRI scan for radiation treatment planning or a post treatment MRI
- Voluntarily signs an IRB approved consent form
Who cannot join
- Inability to obtain informed consent from the patient or their medical power of attorney
- Patients who are not undergoing MR for radiation treatment planning
- Patients who will not have MRI scans after treatment
- Patients with pacemakers or other non-MRI compatible metallic implants
- Pregnant women, by self report using a standard MRI questionnaire
- Patients who will not receive contrast agent as part of their standard MR, will participate only in the non-contrast portion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on the Utility of Advanced MRI Imaging Methods for Radiation Therapy Treatment Planning
The purpose of this study is to determine if it would be helpful to use advanced MRI imaging techniques to take additional views of the tumor target for radiation treatment planning or treatment follow-up MRI.
Read the detailed description
The results of this research project will be used to establish a standard MRI protocol specific to each tumor or disease site. An MRI protocol is a list of MR image types that are acquired for each disease site. These images are used to generate the patient's treatment plan.
- Conditions
- Cancer
- Keywords
- Anal canal, Brain, Breast, Cervix, Esophagus, Gynecology, Head and Neck, Lung, Pancreas, Primary liver or liver metastases, Prostate cancer, Sarcoma
- Medical subject headings
- Neoplasms, Prostatic Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MRI for treatment planning or follow up | MRI for treatment planning for radiation therapy or those who have completed treatment and are receiving follow up care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Successfully Contributing MRI Data
We tested these Advanced MR protocols to evaluate which ones would best visualize the target region. This helped us determine the optimum MR SIM protocols for different sites that became clinical standard.
Measured: up to 4 weeks from imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startFeb 2009
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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-control
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AhunbayE, Medical College of Wisconsin
- Investigators
- Ergun Ahunbay, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340715
- Sponsor's protocol ID
- Advanced MRI
- Status last verified
- Oct 2017
- First submitted
- 10 Sep 2014
- Last updated
- 31 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Khoo VS, Dearnaley DP, Finnigan DJ, Padhani A, Tanner SF, Leach MO. Magnetic resonance imaging (MRI): considerations and applications in radiotherapy treatment planning. Radiother Oncol. 1997 Jan;42(1):1-15. doi: 10.1016/s0167-8140(96)01866-x.
PubMed 9132820
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Utility of Advanced MRI Imaging Methods for Radiation Therapy Treatment Planning
- ClinicalTrials.gov ID
- NCT02340715
- Acronym / sponsor ID
- Advanced MRI
- Conditions
- Cancer
- Keywords
- Anal canal, Brain, Breast, Cervix, Esophagus, Gynecology, Head and Neck, Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Posted 31 Oct 2017
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 determine if it would be helpful to use advanced MRI imaging techniques to take additional views of the tumor target for radiation treatment planning or treatment follow-up MRI.
Detailed description
The results of this research project will be used to establish a standard MRI protocol specific to each tumor or disease site. An MRI protocol is a list of MR image types that are acquired for each disease site. These images are used to generate the patient's treatment plan.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI for treatment planning or follow up | – | –MRI for treatment planning for radiation therapy or those who have completed treatment and are receiving follow up care. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are planning to have radiation therapy for their cancer.
Key inclusion criteria (2 listed)
- Patients aged 18 years older of any race or gender with anal canal, brain, breast, cervix, esophagus, gynecology, head and neck, lung, pancreas, primary liver or liver metastases, prostate cancer or sarcoma either undergoing MRI scan for radiation treatment planning or a post treatment MRI
- Voluntarily signs an IRB approved consent form
Key exclusion criteria (6 listed)
- Inability to obtain informed consent from the patient or their medical power of attorney
- Patients who are not undergoing MR for radiation treatment planning
- Patients who will not have MRI scans after treatment
- Patients with pacemakers or other non-MRI compatible metallic implants
- Pregnant women, by self report using a standard MRI questionnaire
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
Number of Participants Successfully Contributing MRI Data
Time frame: up to 4 weeks from imaging
We tested these Advanced MR protocols to evaluate which ones would best visualize the target region. This helped us determine the optimum MR SIM protocols for different sites that became clinical standard.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9132820Khoo VS, Dearnaley DP, Finnigan DJ, Padhani A, Tanner SF, Leach MO. Magnetic resonance imaging (MRI): considerations and applications in radiotherapy treatment planning. Radiother Oncol. 1997 Jan;42(1):1-15. doi: 10.1016/s0167-8140(96)01866-x.
- Individual participant dataSharing planned: Undecided
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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.
Ergun Ahunbay, PhD principal investigator
Medical College of Wisconsin
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 Cancer, run by Medical College of Wisconsin 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 2 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 31 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?
Yes. Results are posted in the registry (first posted 31 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Successfully Contributing MRI Data (time frame: up to 4 weeks from imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02340715, which also lists 1 linked publication.
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 31 Oct 2017.