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Detection of Bladder Tumors After 30 Min Instillation of Hexvix

Primary Purpose

Bladder Cancer

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Hexvix

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring Hexvix, bladder cancer, cystoscopy, Patients with known or suspicion of bladder cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patients should be indicated for a transurethral resection of the bladder (TURB) based on an outpatient cystoscopy and fulfil the following inclusion criteria:

Patients with multiple bladder tumors, defined as ≥2 lesions, based on an outpatient cystoscopy.
Patients with known urinary urge symptoms or patients who have problems or pain holding back the urine for a time longer than 30 minutes.
Age 18 years or above

Exclusion Criteria:

Patients with known tumors in the prostatic urethra or distal urethra
Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).
Patient with porphyria.
Hypersensitivity to the active substance or to any of the excipients of the solvent
Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
Women of child-bearing potential meaning that only post-menopausal women, women who had their ovaries removed, and women who are otherwise physically unable to bear children can be included.
Patients who have received BCG or chemotherapy within three months prior to study inclusion.
Conditions associated with a risk of poor protocol compliance.
Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the clinical study.
Patients unlikely to comply with protocol

Sites / Locations

LMU Munich

Outcomes

Primary Outcome Measures

Number of lesions

Secondary Outcome Measures

Drug related adverse events

Full Information

NCT ID

NCT01551407

First Posted

March 2, 2012

Last Updated

October 24, 2012

Sponsor

Photocure

1. Study Identification

Unique Protocol Identification Number

NCT01551407

Brief Title

Detection of Bladder Tumors After 30 Min Instillation of Hexvix

Official Title

Open Prospective Within Patient, Phase IIa Study of Hexvix Flexible Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer After 30 Minutes Instillation of Hexvix in Patients With Known or Suspicion of Bladder Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Terminated

Why Stopped

slow inclusion rate

Study Start Date

December 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Photocure

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of the study is to compare Hexvix® flexible cystoscopy and white light flexible cystoscopy in the detection of histological confirmed bladder tumor lesions defined as dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix®.

Detailed Description

This study is an open, prospective, within patient, controlled, multi-center, Phase IIa study in patients with bladder cancer. The bladder of all patients will be instilled with 50 mL Hexvix® 8 mM solution and evacuated after 30 minutes. After bladder evacuation, the bladder will be examined under white light cystoscopy using the Karl Storz flexible videocystoscope. Tumors visible under white light will be mapped. Then the bladder is evaluated with blue light and lesions seen by blue light will be mapped. Biopsies of all visible tumors will be taken using both white and blue light prior to resection of all lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

Hexvix, bladder cancer, cystoscopy, Patients with known or suspicion of bladder cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Hexvix

Intervention Description

50 ml Hexvix liquid instilled once into the bladder for 30 minutes prior to cystoscopy

Primary Outcome Measure Information:

Title

Number of lesions

Time Frame

An average of 15 min (during cystoscopy)

Secondary Outcome Measure Information:

Title

Drug related adverse events

Time Frame

From time of drug instillation until 24 hours after cystoscopy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patients should be indicated for a transurethral resection of the bladder (TURB) based on an outpatient cystoscopy and fulfil the following inclusion criteria: Patients with multiple bladder tumors, defined as ≥2 lesions, based on an outpatient cystoscopy. Patients with known urinary urge symptoms or patients who have problems or pain holding back the urine for a time longer than 30 minutes. Age 18 years or above Exclusion Criteria: Patients with known tumors in the prostatic urethra or distal urethra Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy). Patient with porphyria. Hypersensitivity to the active substance or to any of the excipients of the solvent Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days. Women of child-bearing potential meaning that only post-menopausal women, women who had their ovaries removed, and women who are otherwise physically unable to bear children can be included. Patients who have received BCG or chemotherapy within three months prior to study inclusion. Conditions associated with a risk of poor protocol compliance. Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the clinical study. Patients unlikely to comply with protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Karl, MD

Organizational Affiliation

Department of Urology, LMU Munich, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

LMU Munich

City

Munich

ZIP/Postal Code

D-81377

Country

Germany

12. IPD Sharing Statement

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Detection of Bladder Tumors After 30 Min Instillation of Hexvix

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