NCT00975299

Brief Summary

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-4367 in patients with cancer

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2009

Geographic Reach
2 countries

2 active sites

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

Study Start

First participant enrolled

September 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

1.1 years

First QC Date

September 10, 2009

Last Update Submit

June 25, 2014

Conditions

Diagnostic Imaging

Keywords

NeoplasmPET/CT diagnosisPET tracer

Outcome Measures

Primary Outcomes (1)

  • Visual assessment of lesions

    Day of study drug administration

Secondary Outcomes (7)

  • Quantitative analysis of BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs)

    Day of study drug administration

  • Electrocardiogram (ECG)

    At least 3 times within 8 days after treatment

  • Blood pressure

    At least 3 times within 8 days after treatment

  • Serum protein

    At least 3 times within 8 days after treatment

  • Serum creatinine

    At least 3 times within 8 days after treatment

  • +2 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: BAY86-4367

Arm 2

EXPERIMENTAL
Drug: BAY86-4367

Interventions

BAY86-4367DRUG

Cancer patients, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, PET/CT

Arm 1

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers:
  • males, \>/=50 and \<= 65 years of age
  • Cancer patients:
  • males \>/= 45 years of age
  • patients with recurrent prostate cancer had a positive choline PET/CT for detection, or staging, or restaging of cancer, evaluation of the primary prostate cancer detection rate with BAY 86-4367 in comparison to histology as standard of truth (choline PET/CT is optional).

You may not qualify if:

  • Concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY 86-4367, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
  • Known sensitivity to the study drug or components of the preparation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

München, Bavaria, 81675, Germany

Location

Unknown Facility

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Neoplasms

Interventions

BAY 86-4367

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

September 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

CH(1)DE(1)