Bladder CancerPhase 3NCT00412971
A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
A Phase 3 study testing Hexvix and Standard white light cystoscopy in people with Bladder Cancer, run by Photocure at 2 sites in Denmark.
Trial summary
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Hexvix and Standard white light cystoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 2 sitesDenmark
- Study dates
- Apr 2005to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral resection of the bladder
- Above 18 years
- Written informed consent obtained
Who cannot join
- Gross hematuria. (Note: Gross hematuria 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.
- Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.
- Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
- Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).
- Conditions associated with a risk of poor protocol compliance.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Frederiksberg Hospital
Frederiksberg, 2000
Odense University Hospital
Odense
About this study
Official title: A Randomized, Comparative Phase III, 2-center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.
The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB.
Read the detailed description
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.
Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen is according to standard clinical practice in Denmark.
Recurrence of non-invasive bladder cancer is frequent, and this study is designed to investigate whether Hexvix assisted TURB can reduce the early recurrence compared to standard TURB
- Conditions
- Bladder Cancer
- Being tested
- Hexvix, Standard white light cystoscopy
- Keywords
- Recurrence of bladder cancer, Fluorescence cystoscopy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HexvixDrug
Single installation, TURB
Standard white light cystoscopyOther
| Study group | Role | What they receive |
|---|---|---|
| Hexvix cystoscopy group | Active comparator | Not described Receives: Drug: Hexvix |
| White light | Other | Standard White light cystoscopy Receives: Other: Standard white light cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.
To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.
Measured: 1 year
Secondary outcomes (2)
Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy.
Measured: At day 0
False Positive Detection Rate Patient Level
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startApr 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photocure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregers G Hermann, MD, DM Sci, Principal investigator, Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412971
- Sponsor's protocol ID
- PC B304/04
- Status last verified
- Aug 2013
- First submitted
- 18 Dec 2006
- Last updated
- 11 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Hermann GG, Mogensen K, Carlsson S, Marcussen N, Duun S. Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in Ta/T1 patients: a randomized two-centre study. BJU Int. 2011 Oct;108(8 Pt 2):E297-303. doi: 10.1111/j.1464-410X.2011.10090.x. Epub 2011 Mar 17.
PubMed 21414125
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Comparative Phase III, 2-center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT00412971
- Acronym / sponsor ID
- PC B304/04
- Conditions
- Bladder Cancer
- Keywords
- Recurrence of bladder cancer, Fluorescence cystoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- PhotocureIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Posted 11 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.
The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB.
Detailed description
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.
Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen is according to standard clinical practice in Denmark.
Recurrence of non-invasive bladder cancer is frequent, and this study is designed to investigate whether Hexvix assisted TURB can reduce the early recurrence compared to standard TURB
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hexvix cystoscopy group | Active comparator | Drug: Hexvix |
| White light | Other | Other: Standard white light cystoscopyStandard White light cystoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral resection of the bladder
- Above 18 years
- Written informed consent obtained
Key exclusion criteria (6 listed)
- Gross hematuria. (Note: Gross hematuria 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.
- Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.
- Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
- Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HexvixSingle installation, TURB | Drug | Hexvix cystoscopy group |
| Standard white light cystoscopy | Other | White light |
Primary outcome
Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.
Time frame: 1 year
To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.
2 secondary outcomes
Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy.
Time frame: At day 0
False Positive Detection Rate Patient Level
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21414125Hermann GG, Mogensen K, Carlsson S, Marcussen N, Duun S. Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in Ta/T1 patients: a randomized two-centre study. BJU Int. 2011 Oct;108(8 Pt 2):E297-303. doi: 10.1111/j.1464-410X.2011.10090.x. Epub 2011 Mar 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregers G Hermann, MD, DM Sci principal investigator
Frederiksberg Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hexvix and Standard white light cystoscopy in people with Bladder Cancer, run by Photocure at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2013.