Fluorescence-guided Resection in Breast Cancer | NCT01110954

Studies
Fluorescence-guided Resection in Breast Cancer

NCT01110954

Sponsor

photonamic GmbH & Co. KG

Status

Terminated

Last Update Posted

Apr 4, 2017Actual

Enrollment

8Actual

Phase

Phase 2

Conditions

Breast Tumour

Interventions

PD L 506

Countries

Germany

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 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment

Expanded Access Info

Start Date

May 31, 2010Actual

Primary Completion Date

Jul 19, 2012Actual

Completion Date

Dec 20, 2012Actual

First Submitted Date

Apr 22, 2010

First Submission Date that Met QC Criteria

Apr 23, 2010

First Posted Date

Apr 27, 2010Estimated

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 3, 2017

Last Update Posted Date

Apr 4, 2017Actual

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 an explorative phase II study to investigate the suitability of PD L 506 in the specific intra-operative detection of breast tumour tissue.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PD L 506 2nd dose	Active Comparator	Different dosage	Drug: PD L 506
PD L 506	Experimental		Drug: PD L 506

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PD L 506	Drug	Two different doses will be compared	PD L 506 PD L 506 2nd dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fluorescence intensity in breast cancer tissue		3 h after intake of study medication

Secondary Outcomes

Measure	Description	Time Frame
Laboratory data and adverse events		14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
Caucasian female postmenopausal patients
Patients with histologically confirmed primary palpable and nonpalpable breast cancer sized up to 5 cm (T1 - T2)

Exclusion Criteria:

Suspicious lymphogenic metastases (cN1-3)
Acute or chronic hepatic diseases
Manifest renal diseases with renal dysfunction
Relevant cardiac disease
Preceding therapy of breast tumour under investigation
Patients with multiple attempts of hook-wire placement in preparation of surgery
Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment

Accepts Healthy Volunteers

Sex

Female

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

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided