AzTrials
AzTrials

Cancer, BladderNCT05324033

Sensitivity of Multiparametric MRI in Differentiation Between Muscle Invasive and Non-muscle Invasive Urinary Bladder Cancer

An observational study of Cancer, Bladder, run by Helwan University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Differentiation between non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) is a cornerstone in the treatment plans.Therefore, this study will try to evaluate the sensitivity and reliability of mpMRI in accurate diagnosis of cancer bladder. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cancer, Bladder
What is being tested?
multiparametric MRI on the bladder and diagnostic cystoscopy +/- TURBT
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteEgypt
Study dates
1 May 2022to 1 Apr 2023
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 Any age
  • All sexes
  • Child, Adult, Older adult

Study population: people with suspected cancer bladder

Who may be able to join

  • All patients diagnosed with NMIBC or MIBC during diagnostic cystoscopy or by any radiologic investigation in the Urology department of Helwan university hospitals without being restricted to age or sex.
  • All histological types of bladder cancer
  • Newly diagnosed, recurrent cases, or even patients undergoing follow-up cystoscopy.

Who cannot join

  • Patients with elevated renal function according to their age as this will be a contraindication to DCE MRI.
  • Patients with absolute contraindication to MRI (e.g.: metallic prosthesis).
  • Patients with contraindication to undergo TURBT (e.g.: unfit for surgery).

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of medicine, Helwan university

    Badr, Cairo Governorate, 11829

Other trials in Egypt

About this study

Differentiation between non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) is a cornerstone in the treatment plans.Therefore, this study will try to evaluate the sensitivity and reliability of mpMRI in accurate diagnosis of cancer bladder.

Primary objective: to detect the sensitivity of multiparametric MRI in differentiation between muscle Invasive and non-muscle invasive Urinary Bladder Cancer in relation to the conventional cystoscopy and histopathological examination of the biopsy.

Conditions
Cancer, Bladder
Being tested
multiparametric MRI on the bladder, diagnostic cystoscopy +/- TURBT
Keywords
cancer bladder, multiparametric MRI, VIRADS score
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.

  • multiparametric MRI on the bladderRadiation

    comparison between mpMRI and histopathology

  • diagnostic cystoscopy +/- TURBTProcedure or surgery

    conventional way of diagnosis

Study groups in NCT05324033
Study groupRoleWhat they receive
muscle invasive cancer bladderNot described
Receives: Radiation: multiparametric MRI on the bladder; Procedure: diagnostic cystoscopy +/- TURBT
non-muscle invasive cancer bladderNot described
Receives: Radiation: multiparametric MRI on the bladder; Procedure: diagnostic cystoscopy +/- TURBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to detect the sensitivity of multiparametric MRI in differentiation between muscle Invasive and non-muscle invasive Urinary Bladder Cancer in relation to the conventional cystoscopy and histopathological examination of the biopsy.

    Measured: 6 month

Secondary outcomes (1)

  1. the sensitivity of mpMRI to detect non-visible lesions during follow up cystoscopy while mpMRI reports a positive lesion.

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start1 May 2022
  3. Primary completion1 Feb 2023
  4. Study completion1 Apr 2023

Resources

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 crossover
Time perspective
Cross-sectional
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05324033
Sponsor's protocol ID
REC-FMHU 51/2021
Status last verified
Mar 2023
First submitted
5 Apr 2022
Last updated
4 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bjurlin MA, Carroll PR, Eggener S, Fulgham PF, Margolis DJ, Pinto PA, Rosenkrantz AB, Rubenstein JN, Rukstalis DB, Taneja SS, Turkbey B. Update of the Standard Operating Procedure on the Use of Multiparametric Magnetic Resonance Imaging for the Diagnosis, Staging and Management of Prostate Cancer. J Urol. 2020 Apr;203(4):706-712. doi: 10.1097/JU.0000000000000617. Epub 2019 Oct 23.

    PubMed 31642740

  • Shampo MA, Kyle RA, Steensma DP. Richard Ernst--Nobel Prize for nuclear magnetic resonance spectroscopy. Mayo Clin Proc. 2012 Dec;87(12):e109. doi: 10.1016/j.mayocp.2012.01.023. No abstract available.

    PubMed 23218094

  • Bochner BH, Dalbagni G, Sjoberg DD, Silberstein J, Keren Paz GE, Donat SM, Coleman JA, Mathew S, Vickers A, Schnorr GC, Feuerstein MA, Rapkin B, Parra RO, Herr HW, Laudone VP. Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial. Eur Urol. 2015 Jun;67(6):1042-1050. doi: 10.1016/j.eururo.2014.11.043. Epub 2014 Dec 8.

    PubMed 25496767

  • Chang SS, Bochner BH, Chou R, Dreicer R, Kamat AM, Lerner SP, Lotan Y, Meeks JJ, Michalski JM, Morgan TM, Quale DZ, Rosenberg JE, Zietman AL, Holzbeierlein JM. Treatment of Non-Metastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/ASTRO/SUO Guideline. J Urol. 2017 Sep;198(3):552-559. doi: 10.1016/j.juro.2017.04.086. Epub 2017 Apr 26.

    PubMed 28456635

  • Chavhan, G. (2013). MRI Made Easy (for beginners) (2nd ed., pp. 2-16). JAYPEE BROTHERS MEDICAL PUBLISHERS (P) LTD.

  • Cheung G, Sahai A, Billia M, Dasgupta P, Khan MS. Recent advances in the diagnosis and treatment of bladder cancer. BMC Med. 2013 Jan 17;11:13. doi: 10.1186/1741-7015-11-13.

    PubMed 23327481

  • DeGeorge KC, Holt HR, Hodges SC. Bladder Cancer: Diagnosis and Treatment. Am Fam Physician. 2017 Oct 15;96(8):507-514.

    PubMed 29094888

  • Del Giudice F, Barchetti G, De Berardinis E, Pecoraro M, Salvo V, Simone G, Sciarra A, Leonardo C, Gallucci M, Catalano C, Catto JWF, Panebianco V. Prospective Assessment of Vesical Imaging Reporting and Data System (VI-RADS) and Its Clinical Impact on the Management of High-risk Non-muscle-invasive Bladder Cancer Patients Candidate for Repeated Transurethral Resection. Eur Urol. 2020 Jan;77(1):101-109. doi: 10.1016/j.eururo.2019.09.029. Epub 2019 Nov 5.

    PubMed 31699526

  • Ghai S, Haider MA. Multiparametric-MRI in diagnosis of prostate cancer. Indian J Urol. 2015 Jul-Sep;31(3):194-201. doi: 10.4103/0970-1591.159606.

    PubMed 26166962

  • Petralia G, Summers PE, Agostini A, Ambrosini R, Cianci R, Cristel G, Calistri L, Colagrande S. Dynamic contrast-enhanced MRI in oncology: how we do it. Radiol Med. 2020 Dec;125(12):1288-1300. doi: 10.1007/s11547-020-01220-z. Epub 2020 May 15.

    PubMed 32415476

  • Hawkes RC, Holland GN, Moore WS, Worthington BS. Nuclear magnetic resonance (NMR) tomography of the brain: a preliminary clinical assessment with demonstration of pathology. J Comput Assist Tomogr. 1980 Oct;4(5):577-86. doi: 10.1097/00004728-198010000-00001.

    PubMed 6967878

  • Huang L, Kong Q, Liu Z, Wang J, Kang Z, Zhu Y. The Diagnostic Value of MR Imaging in Differentiating T Staging of Bladder Cancer: A Meta-Analysis. Radiology. 2018 Feb;286(2):502-511. doi: 10.1148/radiol.2017171028. Epub 2017 Dec 4.

    PubMed 29206594

  • Kagawa T, Yoshida S, Shiraishi T et al., Basic principles of magnetic resonance imaging for beginner oral and maxillofacial radiologists. Oral Radiol 33, 92-100 (2017).

  • Kelly, C. R., & Landman, J. (2012, March 29). The Netter Collection of Medical Illustrations - Urinary System. saunders elsevier.

  • Margel D, Alkhateeb SS, Finelli A, Fleshner N. Diminished efficacy of Bacille Calmette-Guerin among elderly patients with nonmuscle invasive bladder cancer. Urology. 2011 Oct;78(4):848-54. doi: 10.1016/j.urology.2011.04.070. Epub 2011 Aug 16.

    PubMed 21840578

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, Bladder, run by Helwan 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 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: finished, as of the sponsor's last update on 4 Apr 2023. 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?

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?

to detect the sensitivity of multiparametric MRI in differentiation between muscle Invasive and non-muscle invasive Urinary Bladder Cancer in relation to the conventional cystoscopy and histopathological examination of the biopsy. (time frame: 6 month). 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 NCT05324033, which also lists 24 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 4 Apr 2023.

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