Trial document




drksid header

  DRKS00003324

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Standard cystoscopy is performed using white light. However, in some cases not all malignant bladder tumours can be detected with this method. New methods for diagnosis of bladder tumours use blue light in combination with a photoactive dye. Photoactive means that the dye needs light to exert its effect. Hypericin accumulates after a certain time selectively in tumour cells but not in healthy cells. Subsequently illuminated with blue light, the tumour areas glow red and can thus be clearly distinguished from the normal bladder mucosa, which does not accumulate the dye. Suspicious tissue can be removed during cystoscopy.

The scope of the clinical study is to collect data on the use of fluorescence cystoscopy with PVP-Hypericin (Hypericin PDD) in the diagnosis of superficial bladder tumours.
Within the clinical study, the number of correctly diagnosed superficial bladder cancer and the number of benign tissue samples taken by mistake are determined. In addition, data on the tolerability and safety of PVP-Hypericin is collected.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

To collect preliminary data on the diagnostic performance of Hypericin-guided cystoscopy regarding the detection of non-muscle invasive bladder cancer. Standard, white light cystoscopy will be compared with Hypericin assisted cystoscopy (PVP-Hypericin instillation; white light followed by blue light (Hypericin PDD)) using a within-patient design by inspecting the bladder under white light first, followed by blue light.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003324
  •   2011/11/11
  •   [---]*
  •   no
  •   Approved
  •   5038/11, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2011-001819-30 
  •   4037502 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C67 -  Malignant neoplasm of bladder
  •   [---]* -  [---]*
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   PVP-Hypericin instillation (225µg Hypericin) for 30+5 minutes, subsequently cystoscopy with white light followed by cystoscopy with blue light
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Diagnostic
  •   Single (group)
  •   IIb
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

To collect preliminary data on the diagnostic performance of Hypericin-guided cystoscopy regarding the detection of non-muscle invasive bladder cancer . Standard, white light cystoscopy will be compared with Hypericin assisted cystoscopy (PVP-Hypericin instillation; white light followed by blue light (Hypericin PDD)) using a within-patient design by
inspecting the bladder under white light first, followed by blue light. Diagnostic performance is confirmed by biopsy.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

• Diagnostic performance regarding flat and papillary tumours
• False-positive rate
• To evaluate systemic absorption and pharmacokinetics (PK) of
Hypericin after a single intravesical instillation of PVP-Hypericin in a
sub-group of patients (N=15-20)
• To assess the safety of PVP-Hypericin (data collection of adverse events)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Austria
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/11/16
  •   220
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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 cystoscpy that have to be diagnosed at the respective study site prior to Visit 1
4. Patients including multiple baldder 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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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
11. All anticoagulation therapy except low dose heparin and aspirin
12. Known allergy to Hypericin, polyvinylpyrrolidone (PVP, povidone) or
any similar compounds
13. Pregnant or breast-feeding women
14. Participation in other clinical studies with investigational drugs
either concurrently or within the last 30 days
15. Previous participation in this clinical study
16. Conditions associated with a risk of poor protocol compliance
17. Patients with mental health problems
18. Patients who have difficulties in understanding the language in
which the patient information is given
19. Legal incapacity and/or other circumstances rendering the patient
unable to understand the nature, scope and possible impact of the study
20. Patients in custody by juridical or official order
21. Staff of the study centre, staff of the sponsor or CRO, the
investigator him-/herself or close relatives of the investigator

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Sanochemia Pharmazeutika AG
    • Boltzmanngasse 11
    • 1090  Wien
    • Austria
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Sanochemia Pharmazeutika AG
    • Ms.  Dr.  Christina  Abrahamsberg 
    • Boltzmanngasse 11
    • 1090  Wien
    • Austria
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address scientific-contact
    • Urologische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München
    • Mr.  Dr.  Michael  Straub 
    • Ismaninger Str. 22
    • 81675  München
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Sanochemia Pharmazeutika AG
    • Ms.  Dr.  Christina  Abrahamsberg 
    • Boltzmanngasse 11
    • 1090  Wien
    • Austria
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Sanochemia Pharmazeutika AG
    • Boltzmanngasse 11
    • 1090  Wien
    • Austria
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/07/19
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   [---]*
end of 1:n-Block publications


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