Bladder CancerNCT03327883
Retrospective Review of FDG PET MRI Management of Patients With Muscle Invasive Bladder Cancer
An observational study of Bladder Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Bladder cancer is a common cancer in the U.S. Survival rates for metastatic bladder cancer have not gotten better for 15 years. Diagnosing and assessing the disease is important for treating it. The best way to tell what stage a cancer is in is computed tomography. This is also called CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2017to 16 Oct 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medical records from patients with metastatic bladder cancer seen between 2013 and 2016 at the NIH Clinical Center. Protocols from which research data originated are 01C0129, 12C0205, 13C0063, and 15C0160.@@@
Who may be able to join
- Patients with metastatic bladder cancer seen between 2013 and 2016 at the NIH Clinical Center.
Who cannot join
- Patients who opted out of storage of specimens/data for future use on prior studies will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Background:
Bladder cancer is a common cancer in the U.S. Survival rates for metastatic bladder cancer have not gotten better for 15 years. Diagnosing and assessing the disease is important for treating it. The best way to tell what stage a cancer is in is computed tomography. This is also called CT. But it does not always give the best images of the bladder. Adding a test called positron emission tomography (PET) can help. Magnetic resonance imaging (MRI) is even better than CT for detecting bladder cancer. But it is not widely used.
Read more
Some people with bladder cancer have already had MRI/PET and CT. Researchers want to study their records. They want to compare the different ways of assessing the disease.
Objective:
To evaluate the use of MRI/PET for diagnosing and treating metastatic bladder cancer.
Eligibility:
People 18 years and older who were in studies between 2013 and 2016
Design:
Researchers will study existing records. There will be no active participants.
The records will have no data that could identify the participants. Data will be stored on secure computers.
No study participants will be contacted without approval from a review board.
Read the detailed description
This protocol is a chart review of the diagnostic imaging and management of patients with metastatic bladder cancer who have undergone PET MRI. The study will involve only review of patient records and will not use specimens or participant contact. The participants whose records will be reviewed in this protocol were enrolled on a number of different protocols between 2013 and 2016.
- Conditions
- Bladder Cancer
- Keywords
- Diagnostic Imaging, Review of Patients Records, PET MRI, Treatment Responses
- Medical subject headings
- Urinary Bladder Neoplasms
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 |
|---|---|---|
| 1/Patients medical records | Medical records of patients with metastatic bladder cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease burden
Comparison of measure of disease burden by PET/MRI versus traditional CT imaging
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start26 Oct 2017
- Primary completion15 Feb 2018
- Study completion16 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrea B Apolo, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327883
- Sponsor's protocol ID
- 999918009
- Other IDs
- 18-C-N009
- Status last verified
- Jul 2021
- First submitted
- 31 Oct 2017
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of FDG PET MRI Management of Patients With Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT03327883
- Acronym / sponsor ID
- 999918009
- Conditions
- Bladder Cancer
- Keywords
- Diagnostic Imaging, Review of Patients Records, PET MRI, Treatment Responses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 1 Nov 2017 (actual)
- 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.
Background:
Bladder cancer is a common cancer in the U.S. Survival rates for metastatic bladder cancer have not gotten better for 15 years. Diagnosing and assessing the disease is important for treating it. The best way to tell what stage a cancer is in is computed tomography. This is also called CT. But it does not always give the best images of the bladder. Adding a test called positron emission tomography (PET) can help. Magnetic resonance imaging (MRI) is even better than CT for detecting bladder cancer. But it is not widely used.
Some people with bladder cancer have already had MRI/PET and CT. Researchers want to study their records. They want to compare the different ways of assessing the disease.
Objective:
To evaluate the use of MRI/PET for diagnosing and treating metastatic bladder cancer.
Eligibility:
People 18 years and older who were in studies between 2013 and 2016
Design:
Researchers will study existing records. There will be no active participants.
The records will have no data that could identify the participants. Data will be stored on secure computers.
No study participants will be contacted without approval from a review board.
Detailed description
This protocol is a chart review of the diagnostic imaging and management of patients with metastatic bladder cancer who have undergone PET MRI. The study will involve only review of patient records and will not use specimens or participant contact. The participants whose records will be reviewed in this protocol were enrolled on a number of different protocols between 2013 and 2016.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Patients medical records | – | –Medical records of patients with metastatic bladder cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical records from patients with metastatic bladder cancer seen between 2013 and 2016 at the NIH Clinical Center. Protocols from which research data originated are 01C0129, 12C0205, 13C0063, and 15C0160.@@@
Key inclusion criteria (1 listed)
- Patients with metastatic bladder cancer seen between 2013 and 2016 at the NIH Clinical Center.
Key exclusion criteria (1 listed)
- Patients who opted out of storage of specimens/data for future use on prior studies will be excluded from this study.
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
Disease burden
Time frame: 1 year
Comparison of measure of disease burden by PET/MRI versus traditional CT imaging
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 9 Jul 2021.
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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.
Andrea B Apolo, M.D. principal investigator
National Cancer Institute (NCI)
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 Bladder Cancer, run by National Cancer Institute (NCI) 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 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 9 Jul 2021. 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?
Disease burden (time frame: 1 year). 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 9 Jul 2021.