Fluorescence-guided Resection in Breast Cancer

NCT ID: NCT01110954

Last Updated: 2017-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-12-20

Brief Summary

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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

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Conditions

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Breast Tumour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PD L 506 2nd dose

Different dosage

Group Type ACTIVE_COMPARATOR

PD L 506

Intervention Type DRUG

Two different doses will be compared

PD L 506

Group Type EXPERIMENTAL

PD L 506

Intervention Type DRUG

Two different doses will be compared

Interventions

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PD L 506

Two different doses will be compared

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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photonamic GmbH & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MK01

Identifier Type: -

Identifier Source: org_study_id

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