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Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-4367 in Patients With Prostate Cancer and Healthy Volunteers

Primary Purpose

Diagnostic Imaging

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BAY86-4367

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 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).

Exclusion Criteria:

Exclusion criteria for all healthy volunteers and patients:
- 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Visual assessment of lesions

Secondary Outcome Measures

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

Electrocardiogram (ECG)

Blood pressure

Serum protein

Serum creatinine

Serum GOT (Glutamat-Oxalacetat-Transaminase)

Adverse events collection

Full Information

NCT ID

NCT00975299

First Posted

September 10, 2009

Last Updated

June 25, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00975299

Brief Title

Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-4367 in Patients With Prostate Cancer and Healthy Volunteers

Official Title

Open-label, Multicenter PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 18F Labeled PET Tracer BAY86-4367 Following a Single Intravenous Administration of 300 MBq (Corresponding to </= 40 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

June 2014

Overall Recruitment Status

Terminated

Study Start Date

September 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Non-Randomized

Enrollment

16 (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)

BAY86-4367

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

BAY86-4367

Intervention Description

Healthy volunteers, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, whole body PET/CT for determination of effective dose., kinetics of BAY86-4367 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 BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs)

Time Frame

Day of study drug administration

Title

Electrocardiogram (ECG)

Time Frame