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PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers

Primary Purpose

Diagnostic Imaging

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Bombesin (68Ga) labeled (BAY86-7548)
Bombesin (68Ga) labeled (BAY86-7548)
Sponsored by
Life Molecular Imaging SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diagnostic Imaging focused on measuring Neoplasm, PET/CT diagnosis, PET tracer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Visual assessment of lesions

Secondary Outcome Measures

Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)
ECG (significant abnormalities)
Blood pressure
Serum protein
Serum creatinine
Serum GOT (Glutamat-Oxalacetat-Transaminase)
Adverse events collection

Full Information

First Posted
September 17, 2010
Last Updated
January 18, 2013
Sponsor
Life Molecular Imaging SA
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1. Study Identification

Unique Protocol Identification Number
NCT01205321
Brief Title
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers
Official Title
Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Life Molecular Imaging SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnostic Imaging
Keywords
Neoplasm, PET/CT diagnosis, PET tracer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bombesin (68Ga) labeled (BAY86-7548)
Intervention Description
Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT
Intervention Type
Drug
Intervention Name(s)
Bombesin (68Ga) labeled (BAY86-7548)
Intervention Description
Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 in blood
Primary Outcome Measure Information:
Title
Visual assessment of lesions
Time Frame
Day of study drug administration
Secondary Outcome Measure Information:
Title
Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)
Time Frame
Day of study drug administration
Title
ECG (significant abnormalities)
Time Frame
At least 3 times until one day after treatment
Title
Blood pressure
Time Frame
At least 3 times until one day after treatment
Title
Serum protein
Time Frame
At least 3 times until one day after treatment
Title
Serum creatinine
Time Frame
At least 3 times until one day after treatment
Title
Serum GOT (Glutamat-Oxalacetat-Transaminase)
Time Frame
At least 3 times until one day after treatment
Title
Adverse events collection
Time Frame
Continuously for at least 5 days after treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Turku
ZIP/Postal Code
FIN-20521
Country
Finland
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers

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