DaBlaCa-8: Comparison of White Light, PDD and NBI in Detection of Flat Dysplasia and CIS at TURB - a Study of Trimodality

• Sponsor: Aarhus University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02313662
• Collaborator: Herlev Hospital (Other), Hospitalsenheden Vest (Other), Oslo University Hospital (Other)
• Enrollment: 153
• Locations: 4
• Duration (Months): 10
• Patients Per Site: 38.3
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

All patients planned for PDD guided TURB can be included in this study. Two different optics with PDD and NBI are applied to the resectoscope in addition to regular WL.

First, a WL cystoscopy is made and any suspect areas are noted on the registration form, then NBI is used and any suspect areas are noted and finally the cystoscopy is made with PDD with registration of any additional findings. To adjust for bias introduced by photo bleaching, the second part of the study will be performed with PDD as the second modality. Any flat lesions will be biopsied if they appear suspicious in one of the modalities.

The registration form is completed by the surgeon, once the pathology results are known.

A total number of 152 patients is planned to be included.

Condition or Disease	Intervention/Treatment	Phase
Narrow Band Imaging and PDD in Cystoscopy	Device: NBI and PDD

Study Design

• Study Type: Observational
• Actual Enrollment: 153 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Trimodalitets-studie Hvidt Lys vs. NBI vs. PDD Ved Detektion af Flad Dysplasi og CIS Ved TURB
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Outcome Measures

Primary Outcome Measures

1. Detection of CIS [Baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing PDD according to the Danish guidelines

Exclusion Criteria:

• Patients not fulfilling the inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark
2	Herlev Hospital	Herlev		Denmark
3	Hospitalsenheden Vest	Holstebro		Denmark
4	Oslo University Hospital	Oslo		Norway	0275

Sponsors and Collaborators

• Aarhus University Hospital
• Herlev Hospital
• Hospitalsenheden Vest
• Oslo University Hospital

Investigators

• Principal Investigator: Jørgen Bjerggaard Jensen, University of Aarhus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jørgen Bjerggaard Jensen, Professor, Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT02313662
• Other Study ID Numbers: DaBlaCa-8
• First Posted: Dec 10, 2014
• Last Update Posted: Dec 29, 2015
• Last Verified: Dec 1, 2015

Study Results

No Results Posted as of Dec 29, 2015