Recurrence of Bladder Cancer After Transurethral Resectio... | NCT00785694

Studies
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

NCT00785694

Sponsor

GE Healthcare

Status

Withdrawn

Last Update Posted

Apr 24, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Bladder Cancer

Interventions

hexaminolevulinate

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Rejected ethics approval in UK and Holland

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Nov 4, 2008

First Submission Date that Met QC Criteria

Nov 4, 2008

First Posted Date

Nov 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2015

Last Update Posted Date

Apr 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B	Experimental	One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.	Drug: hexaminolevulinate
A	No Intervention	Multiple instillations of mitomycin C after transurethral resection in white light alone.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hexaminolevulinate	Drug	Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.	B

Measure	Description	Time Frame
Rate of bladder cancer recurrence		12 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject is not of childbearing potential and signed informed consent.
Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy.

Exclusion Criteria:

The subject was previously included in this study.
The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS).
The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence.
The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract.
The subject has gross haematuria.
The subject has a history of porphyria.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Paul Antonini	GE Healthcare	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GE Healthcare Medical Diagnostics		Vélizy-Villacoublay	Morane Saulnier	78457	France

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C419924	5-aminolevulinic acid hexyl ester

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided