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Radiogenomics for Bladder Cancer

N/A

Waitlist Available

Led By Charles J Rosser, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be > 18 years of age.

Patients must not have had prior definitive treatment for bladder cancer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is testing whether a new MRI technique can improve our ability to stage muscle-invasive bladder cancer, by looking for a ‘radiogenomic signature’.

Who is the study for?

Adults over 18 with suspected muscle invasive bladder cancer (MIBC) who haven't had prior definitive treatment for it. They must be willing to undergo specific MRI imaging, tumor removal surgery (TURBT), and potentially a radical cystectomy if MIBC is confirmed. Participants should not have other active cancers or serious infections, allergies to MRI contrast dye, known distant metastases except certain cases of abdominal/pelvic lymphadenopathy, or be on recent immunosuppressive medications.Check my eligibility

What is being tested?

The trial is testing the combination of advanced 4D MRI imaging and genomic analysis of the tumor cells from patients with suspected MIBC. The goal is to find a radiogenomic signature that could help in accurately staging bladder cancer which may lead to better treatment strategies.See study design

What are the potential side effects?

Since this trial involves MRI imaging and genomic analysis rather than drug interventions, typical medication side effects are not expected. However, there might be risks associated with the use of contrast dye during MRI such as allergic reactions or kidney issues in those with pre-existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have not had any definitive treatment for bladder cancer.

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I do not have cancer in my ureter, urethra, or renal pelvis.

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My kidney function is good, with creatinine below 2 mg/dL or CrCl above 30 ml/min.

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I agree to have advanced MRI scans of my pelvis and standard scans of my abdomen.

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I can understand and am willing to sign the consent form.

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I agree to have a bladder tumor removal surgery as part of my treatment.

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I have a growth in my bladder that may be muscle-invasive bladder cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Who Proceed With MRI Imaging and Sequencing of Bladder Tumor

Trial Design

1Treatment groups

Experimental Treatment

Group I: 4D MRI of pelvis/bladder with genomic analysis of bladder tumorExperimental Treatment2 Interventions

Patients with sessile appearing bladder masses who are destined to undergo transurethral resection of the bladder tumor (TURBT) and are felt by the treating physician to harbor MIBC will be enrolled. Prior to TURBT, ALL subjects will undergo axial imaging for clinical staging in the form of contrast enhanced MRI of the abdomen and pelvis (standard of care). The pelvic MRI will be multiparametric (mp)-4D MRI incorporating high resolution diffusion weighted imaging (HR-DWI). Both the abdominal and pelvic MRI will have an official interpretation by a radiologist, thus both can be used in the care of the subject. Next, ALL subjects will undergo TURBT at which time, voided urine, blood and fresh frozen bladder tumor will be collected. Follow-up pathology will be collected.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

499 Previous Clinical Trials

164,846 Total Patients Enrolled

Charles J Rosser, MDPrincipal InvestigatorCedars-Sinai Medical Center

Media Library

MRI imaging of the pelvis/bladder Clinical Trial Eligibility Overview. Trial Name: NCT04806334 — N/A

Bladder Cancer Research Study Groups: 4D MRI of pelvis/bladder with genomic analysis of bladder tumor

Bladder Cancer Clinical Trial 2023: MRI imaging of the pelvis/bladder Highlights & Side Effects. Trial Name: NCT04806334 — N/A

MRI imaging of the pelvis/bladder 2023 Treatment Timeline for Medical Study. Trial Name: NCT04806334 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open for enrollment to qualified individuals?

"The clinical trial is actively accepting participants, with the initial post on March 2nd 2021 and last updated on September 27th 2022 according to information hosted by clinicaltrials.gov."

Answered by AI

How many individuals are taking part in this research project?

"Affirmative, the information on clinicaltrials.gov reveals that this trial is actively engaging with prospective participants. This initiative was first announced on March 2nd 2021 and most recently updated on September 27th 2022. Furthermore, it necessitates recruiting 20 patients from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiogenomics of Muscle Invasive Bladder Cancer

Charles Rosser 2021. "Radiogenomics of Muscle Invasive Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04806334.

All > Bladder Cancer