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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hexvix cystoscopy group | Active Comparator |
| |
| White light | Other | Standard White light cystoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hexvix | Drug | Single installation, TURB |
| |
| Standard white light cystoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At day 0 | |
| False Positive Detection Rate Patient Level | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregers G Hermann, MD, DM Sci | Frederiksberg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frederiksberg Hospital | Frederiksberg | 2000 | Denmark | |||
| Odense University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21414125 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hexvix Cystoscopy Group | |
| FG001 | White Light | Standard White light cystoscopy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hexvix Cystoscopy Group | |
| BG001 | White Light | Standard White light cystoscopy |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | PP. 145 patients were eligible for tumor recurrence. 12 patients has their last follow up after 12 months. Recurrence after 12 months is based on a total of 133 patients. | Posted | Number | 95% Confidence Interval | precentage of participants | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hexvix Cystoscopy Group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Azotaemi | Renal and urinary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregers G. Hermann | Fredriksberg hospital | (+45) 38163536 | gregershermann@hotmail.com |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C419924 | 5-aminolevulinic acid hexyl ester |
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| Other |
|
| Odense |
| Denmark |
Total of all reporting groups |
| years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 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. | ITT | Posted | Number | 95% Confidence Interval | percentage of participants | At day 0 |
|
|
|
| Secondary | False Positive Detection Rate Patient Level | Posted | Number | percent of patients | 12 months |
|
|
|
| 12 |
| 112 |
| 28 |
| 112 |
| EG001 | White Light | Standard White light cystoscopy | 4 | 118 | 8 | 118 |
| Oesofageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Aortic aneaurysm ruptur | Vascular disorders | Non-systematic Assessment |
|
| Phaumonia | Infections and infestations | Non-systematic Assessment |
|
| Cardiac death | General disorders | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Post procedural haematuria | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Urinary badder haemorrhage | Renal and urinary disorders | Non-systematic Assessment |
|
| Bladder catheter temporary | Surgical and medical procedures | Non-systematic Assessment |
|
| Haemutaria | Renal and urinary disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Hypertention | Vascular disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Bladder perforation | Renal and urinary disorders | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Phyrexia | General disorders | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |