Urinary Bladder CancerNCT05787938
Role of MRI in Assessment of the Urinary Bladder Wall Post Transurethral Tumor Resection
An observational study of Urinary Bladder Cancer, run by Assiut University.
Trial summary
To study the feasibility of using magnetic resonance imaging (MRI) in evaluation UB wall thickening after transurethral resection (TUR) of bladder cancer. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Urinary Bladder Cancer
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Dec 2024
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had a history of TUR of superficial bladder tumors. mainly in older people over the age of 55. most common in men, but it's less common in women.
Who may be able to join
- -Patients who had a history of TUR of superficial bladder tumors and fit for the MRI examination.
Who cannot join
- Patients with pacemaker, claustrophobia or metallic prosthesis which are not MRI compatible.
- Patients with contraindications for cystoscopy (unfit for anesthesia or urethral stricture).
- Patients refusing consent for the study.
Trial locations and contacts
No sites are listed yet.
Samy Abdelaziz, Prof.Doctor contact
About this study
Official title: The Role of Magnetic Resonance Imaging in Assessment of the Urinary Bladder Wall Post Transurethral Tumor Resection
To study the feasibility of using magnetic resonance imaging (MRI) in evaluation UB wall thickening after transurethral resection (TUR) of bladder cancer.
Read the detailed description
Urinary bladder carcinoma is the second most common tumour of the urinary tract and 70% of such carcinomas are non-muscle-invasive (superficial) at presentation. Transurethral resection (TUR) is the standard treatment; however, recurrence of the tumour is not uncommon so such patients require long-term close supervision.
Staging is based on TNM system. Ta tumors are treated with transurethral resection of bladder tumor (TUR-BT). T1 and carcinoma in situ (Tis) tumors have risk of progression and intravesical immunotherapy with Bacillus-Calmette-Guerin (BCG) instillations is used to obtain local control and organ preservation. Invasive bladder cancer (MIBC) is an aggressive disease and standard treatment is radical cystectomy (RC), accompanied by pelvic lymph node dissection (PLND). In addition to radical surgery, neoadjuvant chemotherapy (NAC) has been demonstrated to increase overall survival in MIBC and is recommended by consensus guidelines.
Compared to contrast enhanced CT, MRI has better soft tissue contrast which may improve local tumor evaluation.
Surveillance strategies for urinary bladder carcinoma recurrence have historically relied on cystoscopy, but this procedure has drawbacks, including its high cost, invasiveness and the fact that it may lead to iatrogenic bladder injury and urinary sepsis. In addition, it cannot diagnose upper tract tumours. The presence of a radiological method that could differentiate between benign and malignant lesions of the bladder would avoid the need for invasive cystoscopy, provided that upper tract tumours were excluded. Diffusion-weighted (DW) MRI is a non-invasive technique measuring the microscopic mobility of water molecules in the tissues without contrast administration. It provides information on perfusion and diffusion simultaneously in any organ, so it can be used to differentiate normal and abnormal structures of tissues, and it might help in the characterization of various abnormalities.
During follow-up of patients after trans-urethral resection (TUR), it is difficult to distinguish residual cancer from fibrotic and inflammatory changes secondary to TUR and intravesical chemotherapy, both of which manifest as bladder wall thickening on T2-weighted MRI.
- Conditions
- Urinary Bladder Cancer
- Being tested
- MRI
- 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.
MRIDevice
A procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body. A contrast agent, such as gadolinium, may be injected into a vein to help the tissues and organs show up more clearly in the picture. MRI may be used to help diagnose disease, plan treatment, or find out how well treatment is working. It is especially useful for imaging the brain and spinal cord, the heart and blood vessels, the bones, joints, and other soft tissues, the organs in the pelvis and abdomen, and the breast. Also called magnetic resonance imaging, NMRI, and nuclear magnetic resonance imaging.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Role of Magnetic Resonance Imaging (MRI) in assessment of the urinary bladder wall transurethral tumor resection.
To study the feasibility of using magnetic resonance imaging (MRI) in evaluation UB wall thickening after transurethral resection (TUR) of bladder cancer.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder CancerStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Ibrahim Aboelela, Assiut University
- Investigators
- Amr Farouk Muorad, Prof.Doctor, Principal investigator, Assiut UniversityMohamed Moamen Elbaroudy, doctor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787938
- Sponsor's protocol ID
- MRI in urinary bladder tumors
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El-Assmy A, Abou-El-Ghar ME, Refaie HF, Mosbah A, El-Diasty T. Diffusion-weighted magnetic resonance imaging in follow-up of superficial urinary bladder carcinoma after transurethral resection: initial experience. BJU Int. 2012 Dec;110(11 Pt B):E622-7. doi: 10.1111/j.1464-410X.2012.11345.x. Epub 2012 Jul 3.
PubMed 22757606Wang Y, Zhang W, Xiao W, Chen S, Wei Y, Luo M. Feasibility of Early Evaluation for the Recurrence of Bladder Cancer after Trans-Urethral Resection: A Comparison between Magnetic Resonance Imaging and Multidetector Computed Tomography. Tomography. 2022 Dec 22;9(1):25-35. doi: 10.3390/tomography9010003.
PubMed 36648990Webb JA. Imaging in haematuria. Clin Radiol. 1997 Mar;52(3):167-71. doi: 10.1016/s0009-9260(97)80269-3. No abstract available.
PubMed 9091250Le Bihan D, Breton E, Lallemand D, Aubin ML, Vignaud J, Laval-Jeantet M. Separation of diffusion and perfusion in intravoxel incoherent motion MR imaging. Radiology. 1988 Aug;168(2):497-505. doi: 10.1148/radiology.168.2.3393671.
PubMed 3393671Dobson MJ, Carrington BM, Collins CD, Ryder WD, Read G, Hutchinson CE, Hawnaur JM. The assessment of irradiated bladder carcinoma using dynamic contrast-enhanced MR imaging. Clin Radiol. 2001 Feb;56(2):94-8. doi: 10.1053/crad.2000.0560.
PubMed 11222064
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Magnetic Resonance Imaging in Assessment of the Urinary Bladder Wall Post Transurethral Tumor Resection
- ClinicalTrials.gov ID
- NCT05787938
- Acronym / sponsor ID
- MRI in urinary bladder tumors
- Conditions
- Urinary Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 28 Mar 2023 (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.
To study the feasibility of using magnetic resonance imaging (MRI) in evaluation UB wall thickening after transurethral resection (TUR) of bladder cancer.
Detailed description
Urinary bladder carcinoma is the second most common tumour of the urinary tract and 70% of such carcinomas are non-muscle-invasive (superficial) at presentation. Transurethral resection (TUR) is the standard treatment; however, recurrence of the tumour is not uncommon so such patients require long-term close supervision.
Staging is based on TNM system. Ta tumors are treated with transurethral resection of bladder tumor (TUR-BT). T1 and carcinoma in situ (Tis) tumors have risk of progression and intravesical immunotherapy with Bacillus-Calmette-Guerin (BCG) instillations is used to obtain local control and organ preservation. Invasive bladder cancer (MIBC) is an aggressive disease and standard treatment is radical cystectomy (RC), accompanied by pelvic lymph node dissection (PLND). In addition to radical surgery, neoadjuvant chemotherapy (NAC) has been demonstrated to increase overall survival in MIBC and is recommended by consensus guidelines.
Compared to contrast enhanced CT, MRI has better soft tissue contrast which may improve local tumor evaluation.
Surveillance strategies for urinary bladder carcinoma recurrence have historically relied on cystoscopy, but this procedure has drawbacks, including its high cost, invasiveness and the fact that it may lead to iatrogenic bladder injury and urinary sepsis. In addition, it cannot diagnose upper tract tumours. The presence of a radiological method that could differentiate between benign and malignant lesions of the bladder would avoid the need for invasive cystoscopy, provided that upper tract tumours were excluded. Diffusion-weighted (DW) MRI is a non-invasive technique measuring the microscopic mobility of water molecules in the tissues without contrast administration. It provides information on perfusion and diffusion simultaneously in any organ, so it can be used to differentiate normal and abnormal structures of tissues, and it might help in the characterization of various abnormalities.
During follow-up of patients after trans-urethral resection (TUR), it is difficult to distinguish residual cancer from fibrotic and inflammatory changes secondary to TUR and intravesical chemotherapy, both of which manifest as bladder wall thickening on T2-weighted MRI.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had a history of TUR of superficial bladder tumors. mainly in older people over the age of 55. most common in men, but it's less common in women.
Key inclusion criteria (1 listed)
- -Patients who had a history of TUR of superficial bladder tumors and fit for the MRI examination.
Key exclusion criteria (3 listed)
- Patients with pacemaker, claustrophobia or metallic prosthesis which are not MRI compatible.
- Patients with contraindications for cystoscopy (unfit for anesthesia or urethral stricture).
- Patients refusing consent for the study.
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 |
|---|---|---|
| MRIA procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body. A contrast agent, such as gadolinium, may be injected into a vein to help the tissues and organs show up more clearly in the picture. MRI may be used to help diagnose disease, plan treatment, or find out how well treatment is working. It is especially useful for imaging the brain and spinal cord, the heart and blood vessels, the bones, joints, and other soft tissues, the organs in the pelvis and abdomen, and the breast. Also called magnetic resonance imaging, NMRI, and nuclear magnetic resonance imaging. | Device | – |
Primary outcome
The Role of Magnetic Resonance Imaging (MRI) in assessment of the urinary bladder wall transurethral tumor resection.
Time frame: Baseline
To study the feasibility of using magnetic resonance imaging (MRI) in evaluation UB wall thickening after transurethral resection (TUR) of bladder cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Background: PubMed 22757606El-Assmy A, Abou-El-Ghar ME, Refaie HF, Mosbah A, El-Diasty T. Diffusion-weighted magnetic resonance imaging in follow-up of superficial urinary bladder carcinoma after transurethral resection: initial experience. BJU Int. 2012 Dec;110(11 Pt B):E622-7. doi: 10.1111/j.1464-410X.2012.11345.x. Epub 2012 Jul 3.
- Background: PubMed 36648990Wang Y, Zhang W, Xiao W, Chen S, Wei Y, Luo M. Feasibility of Early Evaluation for the Recurrence of Bladder Cancer after Trans-Urethral Resection: A Comparison between Magnetic Resonance Imaging and Multidetector Computed Tomography. Tomography. 2022 Dec 22;9(1):25-35. doi: 10.3390/tomography9010003.
- Background: PubMed 9091250Webb JA. Imaging in haematuria. Clin Radiol. 1997 Mar;52(3):167-71. doi: 10.1016/s0009-9260(97)80269-3. No abstract available.
- Background: PubMed 3393671Le Bihan D, Breton E, Lallemand D, Aubin ML, Vignaud J, Laval-Jeantet M. Separation of diffusion and perfusion in intravoxel incoherent motion MR imaging. Radiology. 1988 Aug;168(2):497-505. doi: 10.1148/radiology.168.2.3393671.
- Background: PubMed 11222064Dobson MJ, Carrington BM, Collins CD, Ryder WD, Read G, Hutchinson CE, Hawnaur JM. The assessment of irradiated bladder carcinoma using dynamic contrast-enhanced MR imaging. Clin Radiol. 2001 Feb;56(2):94-8. doi: 10.1053/crad.2000.0560.
Related trials for Urinary Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Samy Abdelaziz, Prof.Doctor contact
Amr Farouk Muorad, Prof.Doctor principal investigator
Assiut University
Mohamed Moamen Elbaroudy, doctor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Cancer, run by Assiut University.
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 3 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Ayat Ibrahim, Resident Doctor (01068306016, ayatibrahim59@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Role of Magnetic Resonance Imaging (MRI) in assessment of the urinary bladder wall transurethral tumor resection. (time frame: Baseline). 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 NCT05787938, which also lists 5 linked publications.
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 28 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.