NCT01205321

Brief Summary

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2010

Geographic Reach
3 countries

3 active sites

Status
completed

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

September 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

September 17, 2010

Last Update Submit

January 18, 2013

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 BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)

    Day of study drug administration

  • ECG (significant abnormalities)

    At least 3 times until one day after treatment

  • Blood pressure

    At least 3 times until one day after treatment

  • Serum protein

    At least 3 times until one day after treatment

  • Serum creatinine

    At least 3 times until one day after treatment

  • +2 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Bombesin (68Ga) labeled (BAY86-7548)

Arm 2

EXPERIMENTAL
Drug: Bombesin (68Ga) labeled (BAY86-7548)

Interventions

Bombesin (68Ga) labeled (BAY86-7548)DRUG

Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 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 had an MRI of the prostate and/or a positive choline or acetate PET/CT for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary prostate cancer patients) of recurrence prostate cancer and the primary cancer disease is/ will be histologically confirmed.
  • The prostate cancer is histologically confirmed and results of histology are available.
  • Patients with primary prostate cancer: \>/= 20 percent of biopsy material should be affected by cancer in the histopathological evaluation.
  • Patients with primary prostate cancer: Patient is scheduled to undergo prostatectomy.

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 BAY86-7548, 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 (3)

Unknown Facility

Turku, FIN-20521, Finland

Location

Unknown Facility

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Unknown Facility

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Neoplasms

Interventions

BombesinProduct LabelingBAY 86-7548

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteinsAmphibian VenomsVenomsComplex MixturesToxins, BiologicalBiological FactorsProduct PackagingIndustryTechnology, Industry, and Agriculture

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 17, 2010

First Posted

September 20, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

DE(1)CH(1)FI(1)