Muscle Invasive Bladder Cancer"NAC-MRI"NCT07202819
Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy
A study testing Neoadjuvant Chemotherapy and Radical Cystectomy in people with Muscle Invasive Bladder Cancer, run by Assiut University at 2 sites in Egypt.
Trial summary
The goal of this clinical trial is to learn if neoadjuvant chemotherapy (NAC) affects the accuracy of magnetic resonance imaging (MRI) in staging muscle-invasive bladder cancer (MIBC). This study will also assess how tissue changes induced by NAC impact MRI interpretation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Cancer
- What is being tested?
- Neoadjuvant Chemotherapy and Radical Cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Sep 2025to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients diagnosed with cT2 urothelial carcinoma of the urinary bladder, according to the TNM classification, who give informed, written consent on participation in the study and approve all its requirements.
Who cannot join
- Patients who have received pelvic radiotherapy.
- Previous open or laparoscopic pelvic surgery.
- Patients with contraindications to MRI.
- Patients who are unfit for or refuse radical cystectomy.
- Ineligibility to cisplatin.
- squamous differentiation in the histopathology
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Not yet recruiting
Urology Department, Faculty of Medicine, Assiut University
Asyut, Asyut Governorate, 71515
Hamza Elhashamy, MBBCh, +201028635437, Hamza.Ahmed00099@med.aun.edu.eg
Abdelrahman Abdelshafi, MBBCh, +201123740500, abdulrahman.18313572@med.aun.edu.eg
- Recruiting
Urology Department, Faculty of Medicine, Assiut University
Asyut, Asyut Governorate, 71515
Amr Esam Darwish, MD, 01015817851, amrdarwish@aun.edu.eg
About this study
Official title: Does Neoadjuvant Chemotherapy Affect the Accuracy of Magnetic Resonance Imaging Before Radical Cystectomy? A Randomized Controlled Trial.
The goal of this clinical trial is to learn if neoadjuvant chemotherapy (NAC) affects the accuracy of magnetic resonance imaging (MRI) in staging muscle-invasive bladder cancer (MIBC). This study will also assess how tissue changes induced by NAC impact MRI interpretation. The main questions it aims to answer are:
Does NAC compromise the accuracy of MRI in staging MIBC?
Read more
Does NAC-induced tissue change affect the reliability of MRI in tumor assessment?
Researchers will compare MRI staging accuracy in MIBC patients who received NAC to those who went directly to surgery, to see if NAC impacts MRI's diagnostic performance.
Participants will:
Undergo MRI scanning before surgery
Receive either NAC or go directly to surgery, depending on their group assignment
Have their MRI results compared to histopathological outcomes after surgery
- Conditions
- Muscle Invasive Bladder Cancer
- Being tested
- Neoadjuvant Chemotherapy, Radical Cystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant ChemotherapyDrug
Also called NAC
Standard neoadjuvant chemotherapy for muscle-invasive bladder cancer, typically consisting of cisplatin-based regimens such as MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin) or gemcitabine and cisplatin. Administered prior to radical cystectomy to shrink the tumor and improve surgical outcomes. The post-treatment MRI findings will be analyzed for correlation with histopathological results after surgery.
Radical CystectomyProcedure or surgery
Also called RC
Surgical removal of the urinary bladder, typically performed in patients with muscle-invasive bladder cancer. In this study, participants in both arms will undergo radical cystectomy, either directly or following neoadjuvant chemotherapy. Histopathological examination of surgical specimens will be compared with MRI findings for staging accuracy assessment.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemotherapy Arm | Active comparator | Participants in this arm will receive standard-of-care neoadjuvant chemotherapy (NAC) before undergoing radical cystectomy for muscle-invasive bladder cancer (MIBC). MRI will be performed post-NAC for local tumor restaging, and the results will be compared to histopathology to evaluate the diagnostic accuracy of MRI. Receives: Drug: Neoadjuvant Chemotherapy; Procedure: Radical Cystectomy |
| Radical cystectomy-Only arm | Active comparator | Participants in this arm will undergo immediate radical cystectomy without receiving neoadjuvant chemotherapy. MRI will be performed preoperatively for local tumor staging, and results will be compared with post-surgical histopathology to assess the accuracy of MRI in this setting. Receives: Procedure: Radical Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the accuracy of MRI between patients who received and those who didn't receive NAC
This outcome aims to evaluate and compare the diagnostic accuracy of MRI in detecting tumor stage in bladder cancer patients who underwent NAC prior to radical cystectomy versus those who did not receive NAC.
Measured: At the time of radical cystectomy and final histopathology report (approximately 3 to 6 months after starting NAC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Sep 2025
- Primary completion20 May 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Esam Saad Mohamed Darwish, Assiut University
- Investigators
- Amr Darwish, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202819
- Sponsor's protocol ID
- PreIRB-Assiut-URO001
- Acronym
- "NAC-MRI"
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Neoadjuvant Chemotherapy Affect the Accuracy of Magnetic Resonance Imaging Before Radical Cystectomy? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07202819
- Acronym / sponsor ID
- "NAC-MRI" / PreIRB-Assiut-URO001
- Conditions
- Muscle Invasive Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 2 Oct 2025 (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 goal of this clinical trial is to learn if neoadjuvant chemotherapy (NAC) affects the accuracy of magnetic resonance imaging (MRI) in staging muscle-invasive bladder cancer (MIBC). This study will also assess how tissue changes induced by NAC impact MRI interpretation. The main questions it aims to answer are:
Does NAC compromise the accuracy of MRI in staging MIBC?
Does NAC-induced tissue change affect the reliability of MRI in tumor assessment?
Researchers will compare MRI staging accuracy in MIBC patients who received NAC to those who went directly to surgery, to see if NAC impacts MRI's diagnostic performance.
Participants will:
Undergo MRI scanning before surgery
Receive either NAC or go directly to surgery, depending on their group assignment
Have their MRI results compared to histopathological outcomes after surgery
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemotherapy Arm | Active comparator | Drug: Neoadjuvant Chemotherapy, Procedure: Radical CystectomyParticipants in this arm will receive standard-of-care neoadjuvant chemotherapy (NAC) before undergoing radical cystectomy for muscle-invasive bladder cancer (MIBC). MRI will be performed post-NAC for local tumor restaging, and the results will be compared to histopathology to evaluate the diagnostic accuracy of MRI. |
| Radical cystectomy-Only arm | Active comparator | Procedure: Radical CystectomyParticipants in this arm will undergo immediate radical cystectomy without receiving neoadjuvant chemotherapy. MRI will be performed preoperatively for local tumor staging, and results will be compared with post-surgical histopathology to assess the accuracy of MRI in this setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with cT2 urothelial carcinoma of the urinary bladder, according to the TNM classification, who give informed, written consent on participation in the study and approve all its requirements.
Key exclusion criteria (6 listed)
- Patients who have received pelvic radiotherapy.
- Previous open or laparoscopic pelvic surgery.
- Patients with contraindications to MRI.
- Patients who are unfit for or refuse radical cystectomy.
- Ineligibility to cisplatin.
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 |
|---|---|---|
| Neoadjuvant ChemotherapyAlso: NACStandard neoadjuvant chemotherapy for muscle-invasive bladder cancer, typically consisting of cisplatin-based regimens such as MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin) or gemcitabine and cisplatin. Administered prior to radical cystectomy to shrink the tumor and improve surgical outcomes. The post-treatment MRI findings will be analyzed for correlation with histopathological results after surgery. | Drug | Neoadjuvant Chemotherapy Arm |
| Radical CystectomyAlso: RCSurgical removal of the urinary bladder, typically performed in patients with muscle-invasive bladder cancer. In this study, participants in both arms will undergo radical cystectomy, either directly or following neoadjuvant chemotherapy. Histopathological examination of surgical specimens will be compared with MRI findings for staging accuracy assessment. | Procedure or surgery | Neoadjuvant Chemotherapy Arm, Radical cystectomy-Only arm |
Primary outcome
Compare the accuracy of MRI between patients who received and those who didn't receive NAC
Time frame: At the time of radical cystectomy and final histopathology report (approximately 3 to 6 months after starting NAC)
This outcome aims to evaluate and compare the diagnostic accuracy of MRI in detecting tumor stage in bladder cancer patients who underwent NAC prior to radical cystectomy versus those who did not receive NAC.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Muscle Invasive 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 1
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Non-muscle Invasive Bladder Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis
RecruitingObservational study
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Non-Muscle Invasive Bladder Cancer
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.
Amr Darwish, Lecturer principal investigator
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoadjuvant Chemotherapy and Radical Cystectomy in people with Muscle Invasive Bladder Cancer, run by Assiut University at 2 sites 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 1 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: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamza Elhashamy, MBBCh (+201028635437, Hamza.Ahmed00099@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the accuracy of MRI between patients who received and those who didn't receive NAC (time frame: At the time of radical cystectomy and final histopathology report (approximately 3 to 6 months after starting NAC)). 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 2 Oct 2025.