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PDT for Bladder Cancer
Study Summary
This trial is for patients with bladder cancer who have not responded to other treatments or who can't tolerate other treatments. The trial will consist of 100 patients who will have two treatments of a new drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I cannot or do not want to undergo major bladder surgery.I don't have any health issues that would interfere with the study.I am not on any treatments that are not allowed in this study.I am using two forms of birth control or am not having sex to join the study.I can hold my bladder for at least 60 minutes.I currently have an infection that needs treatment with medication.I cannot have general or spinal anesthesia due to health reasons.I am intolerant to BCG or it did not work for me despite receiving multiple doses.I have another cancer, but it's either not growing or is a type that doesn't need active treatment.My bladder cancer is confirmed high grade and not muscle-invasive.I am a woman who can have children and have a negative pregnancy test.I am a woman who can have children and have a negative pregnancy test.My bladder cancer is confirmed and graded with a recent test.I have a specific type of bladder cancer that has not spread beyond certain areas.I am over 18 years old.My bladder cancer has invaded the muscle layer or spread to other parts.I am currently experiencing visible blood in my urine.I haven't had bladder chemotherapy in the last month, except for a one-time dose right after bladder tumor surgery.I am able to care for myself and perform daily activities.
- Group 1: 0.7 mg/cm^2 Ruvidar® (TLD-1433) Bladder infusion and Photodynamic Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research endeavor actively seeking participants?
"Affirmative. The clinical trial is open for recruitment as indicated on the clinicaltrials.gov website, with a post date of August 30th 2019 and an update from May 6th 2022. A total of 100 individuals are needed at 11 distinct medical facilities."
How many participants have enrolled in this clinical experiment?
"Affirmative, according to the clinicaltrials.gov listing this trial is recruiting participants as of today. This medical research was initially posted on August 30th 2019 and has been recently updated on May 6th 2022 with a goal of enrolling 100 subjects across 11 locations."
How many sites are overseeing the administration of this clinical trial?
"11 trial sites have begun enrolling patients, including Virginia Urology in Richmond (Site 02009), University Health Network in Toronto (Site 01001) and The Vancouver Prostate Centre - Diamond Health Care Centre in Vancouver (Site 01005). Additionally, there are 8 other locations where enrolment is possible."
Has the FDA granted its seal of approval to TLD-1433 Bladder infusion and Photodynamic Therapy?
"After taking into account the Phase 2 status of this medical trial, our team at Power assigned TLD-1433 Bladder infusion and Photodynamic Therapy a safety rating of 2 due to existing data confirming its security but no evidence yet affirming efficacy."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What site did they apply to?
How responsive is this trial?
Typically responds via
Average response time
- < 2 Days
Most responsive sites:
- Site 02008 - MidLantic Urology: < 48 hours
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