Bladder CancerNCT03914001
Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study
A study testing mpMRI and Second look TURBT in people with Bladder Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of the study is to prospectively assess the role of mpMRI as a non invasive method for assessment of possible residual tumor after initial resection of non muscle invasive bladder tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- mpMRI and Second look TURBT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 1 Jun 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give informed consent.
- Patients with primary or recurrent papillary NMIBC.
- Normal cardiac, hematological, and renal functions.
Who cannot join
- 1. Patients with history of previous radiotherapy or systemic chemotherapy. 2. Patients suffering from immuno-deficiency or other malignancies. 3. Patients with high serum creatinine (more than 2 mg/dl). 4. Patients with contraindication to MRI (claustrophobia-pacemaker- metallic prosthesis).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, DK, 35516
Amr A. Elsawy, MD, 0020502202222, amrelsawy.unc@hotmail.com
About this study
The aim of the study is to prospectively assess the role of mpMRI as a non invasive method for assessment of possible residual tumor after initial resection of non muscle invasive bladder tumor.
Read the detailed description
Comprehensive multiparametric (mp) MRI which includes T2 weighted imaging, dynamic contrast enhanced (DCE) imaging and DWI, was proven to be efficient tool in differentiating benign and malignant bladder lesion. morphological characterization of malignant bladder lesion (mapping/size/morphology/stalk), T stage differentiation and histological grade discrimination.
The application of mpMRI in NMIBC with its added value as non invasive tool for initial staging and after primary resection could be a new helpful method for better diagnosis, risk categorization, refining the indications of second resection and proper determination of adjuvant treatment.
- Conditions
- Bladder Cancer
- Being tested
- mpMRI, Second look TURBT
- Keywords
- Non muscle invasive bladder cancer, multiparametric magnetic resonance imaging, second resection
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mpMRIDevice
all eligible patients will undergo mpMRI 4 weks after initial TURBT
Second look TURBTProcedure or surgery
after mpMRI all patients will subjected to second look TURBT
| Study group | Role | What they receive |
|---|---|---|
| NMIBC patients | Other | eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks Receives: Device: mpMRI; Procedure: Second look TURBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT
assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT by comparing the results obtained by pre-second look TURBT mpMRI (Test of the study) with results of second look biopsy whether benign or malignant (Standard test).
Measured: 1 year
Secondary outcomes (8)
Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions.
Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions.
Measured: 1 year
2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease.
2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease.
Measured: 1 year
Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT.
Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT.
Measured: 1 year
Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization).
Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization).
Measured: 1 year
Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series.
Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series.
Measured: 1 year
Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT.
Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT.
Measured: 1 year
Readmission rate after second look TURBT.
Readmission rate after second look TURBT.
Measured: 1 year
Cost comparison of mpMRI and second look TURBT.
Cost comparison of mpMRI and second look TURBT.
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 posted12 Apr 2019
- Study start1 Apr 2019
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
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 Mansoura UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel-Lateif El-Sawy, Mansoura University
- Investigators
- Ahmed Mosbah, Study chair, Urology and Nephrology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914001
- Sponsor's protocol ID
- AE 2390
- Status last verified
- Apr 2019
- First submitted
- 6 Apr 2019
- Last updated
- 12 Apr 2019
- 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 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study
- ClinicalTrials.gov ID
- NCT03914001
- Acronym / sponsor ID
- AE 2390
- Conditions
- Bladder Cancer
- Keywords
- Non muscle invasive bladder cancer, multiparametric magnetic resonance imaging, second resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 12 Apr 2019 (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.
The aim of the study is to prospectively assess the role of mpMRI as a non invasive method for assessment of possible residual tumor after initial resection of non muscle invasive bladder tumor.
Detailed description
Comprehensive multiparametric (mp) MRI which includes T2 weighted imaging, dynamic contrast enhanced (DCE) imaging and DWI, was proven to be efficient tool in differentiating benign and malignant bladder lesion. morphological characterization of malignant bladder lesion (mapping/size/morphology/stalk), T stage differentiation and histological grade discrimination.
The application of mpMRI in NMIBC with its added value as non invasive tool for initial staging and after primary resection could be a new helpful method for better diagnosis, risk categorization, refining the indications of second resection and proper determination of adjuvant treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NMIBC patients | Other | Device: mpMRI, Procedure: Second look TURBTeligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to give informed consent.
- Patients with primary or recurrent papillary NMIBC.
- Normal cardiac, hematological, and renal functions.
Key exclusion criteria (1 listed)
- 1. Patients with history of previous radiotherapy or systemic chemotherapy. 2. Patients suffering from immuno-deficiency or other malignancies. 3. Patients with high serum creatinine (more than 2 mg/dl). 4. Patients with contraindication to MRI (claustrophobia-pacemaker- metallic prosthesis).
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 |
|---|---|---|
| mpMRIall eligible patients will undergo mpMRI 4 weks after initial TURBT | Device | NMIBC patients |
| Second look TURBTafter mpMRI all patients will subjected to second look TURBT | Procedure or surgery | NMIBC patients |
Primary outcome
assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT
Time frame: 1 year
assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT by comparing the results obtained by pre-second look TURBT mpMRI (Test of the study) with results of second look biopsy whether benign or malignant (Standard test).
8 secondary outcomes
Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions.
Time frame: 1 year
2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease.
Time frame: 1 year
Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT.
Time frame: 1 year
Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization).
Time frame: 1 year
Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series.
Time frame: 1 year
Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT.
Time frame: 1 year
Readmission rate after second look TURBT.
Time frame: 1 year
Cost comparison of mpMRI and second look TURBT.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
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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.
Ahmed Mosbah study chair
Urology and Nephrology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mpMRI and Second look TURBT in people with Bladder Cancer, run by Mansoura University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Apr 2019. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr A Elsawy, MD (0502202222, amrelsawy.unc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT (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 12 Apr 2019.