NCT01110954

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2012

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

2.1 years

First QC Date

April 22, 2010

Last Update Submit

April 3, 2017

Conditions

Breast Tumour

Outcome Measures

Primary Outcomes (1)

  • Fluorescence intensity in breast cancer tissue

    3 h after intake of study medication

Secondary Outcomes (1)

  • Laboratory data and adverse events

    14 days

Study Arms (2)

PD L 506 2nd dose

ACTIVE COMPARATOR

Different dosage

Drug: PD L 506

PD L 506

EXPERIMENTAL
Drug: PD L 506

Interventions

PD L 506DRUG

Two different doses will be compared

PD L 506PD L 506 2nd dose

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Munich, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2010

First Posted

April 27, 2010

Study Start

May 31, 2010

Primary Completion

July 19, 2012

Study Completion

December 20, 2012

Last Updated

April 4, 2017

Record last verified: 2017-04

Locations

DE(1)