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Clinical Trials/EUCTR2011-001819-30-AT
EUCTR2011-001819-30-AT
Active, not recruiting
Not Applicable

Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy (Hypericin PDD)

Sanochemia Pharmazeutika AG0 sites220 target enrollmentJuly 22, 2011
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ConditionsSuspected non-muscle invasive (superficial) bladder cancerMedDRA version: 17.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suspected non-muscle invasive (superficial) bladder cancer
Sponsor
Sanochemia Pharmazeutika AG
Enrollment
220
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 22, 2011
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients who have given their signed declaration of consent and data protection declaration
  • •2\. Males and females aged \= 18 years
  • •3\. Patients scheduled for transurethral resection of the bladder of a suspected bladder cancer based on recent findings in cystoscopy that have to be diagnosed at the respective study site prior to Visit 1
  • •4\. Patients including multiple bladder tumours or suspicious lesions
  • •5\. Patients with initial and/or recurrent bladder cancer
  • •6\. Patients with adequate renal and hepatic function according to the investigator
  • •7\. No known anaesthetic risks (risk of narcosis ASA 1\-3\)
  • •8\. All women of child\-bearing potential must have a negative serum or urine pregnancy test at screening and must use hormonal contraception or intrauterine device (IUD) during the treatment and for at least one month thereafter.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •1\. Intravesical BCG (Bacillus Calmette\-Guérin) instillation \= 6 months
  • •2\. Intravesical Mitomycin instillation \= 3 months
  • •3\. Patients at high risk of suffering extensive bladder inflammation
  • •4\. Recent bladder surgery (resection) \= 3 months
  • •5\. Patients with symptoms and signs of urinary tract infection, e.g. moderate or severe leukocyturia, dysuria, alguria, urgency, frequency, polyuria, offensive urine, cloudy urine, significant bacteriuria (\= 100000 CFU/mL), positive urine culture, asymptomatic bacteriuria, suprapubic tenderness, pain or pressure, flank or back pain, fever \= 38°C, costovertebral angle tenderness
  • •6\. Macroscopic hematuria
  • •7\. Bladder stones
  • •8\. Bladder capacity \= 50 mL
  • •9\. Administration of any other photosensitiser \< 6 months
  • •10\. Oral intake of any drug or substance containing Hypericum extract, Hypericin, Pseudohypericin or parts of Hypericum plants (capsules, tablets, powder, drops, teas, etc.) within 14 days prior to PDD, during the study and until Visit 4 for patients included in the PK subgroup

Outcomes

Primary Outcomes

Not specified

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