Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004099

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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®.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00004099
  •   2012/10/09
  •   2012/03/02
  •   no
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Secondary IDs

  •   NCT01551407  (ClinicalTrials.gov)
  •   PC B202/11  (PhotoCure)
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Health Condition or Problem studied

  •   Bladder Cancer
  •   C67 -  Malignant neoplasm of bladder
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Interventions/Observational Groups

  •   Drug: Hexvix
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   II
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Primary Outcome

- Number of lesions; time frame: An average of 15 min (during cystoscopy)

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Secondary Outcome

- Drug related adverse events; time frame: From time of drug instillation until 24 hours after cystoscopy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/12/31
  •   34
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Photocure
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    • Department of Urology, LMU Munich, Germany
    • Alexander Karl, MD 
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    • Department of Urology, LMU Munich, Germany
    • Alexander Karl, MD 
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    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   2012/06/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.