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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diagnostic Imaging	Drug: Bombesin (68Ga) labeled (BAY86-7548)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
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

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Piramal Imaging SA:

Primary Outcome Measures:

Visual assessment of lesions [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs) [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]
ECG (significant abnormalities) [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
Blood pressure [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
Serum protein [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
Serum creatinine [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
Serum GOT (Glutamat-Oxalacetat-Transaminase) [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
Adverse events collection [ Time Frame: Continuously for at least 5 days after treatment ] [ Designated as safety issue: Yes ]

Enrollment:	19
Study Start Date:	November 2010
Study Completion Date:	December 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Bombesin (68Ga) labeled (BAY86-7548) Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT
Experimental: Arm 2	Drug: Bombesin (68Ga) labeled (BAY86-7548) 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

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205321

Locations

Finland

Turku, Finland, FIN-20521
Germany

Ulm, Baden-Württemberg, Germany, 89081
Switzerland

Zürich, Switzerland, 8091

Sponsors and Collaborators

Piramal Imaging SA

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Piramal Imaging SA
ClinicalTrials.gov Identifier:	NCT01205321 History of Changes
Other Study ID Numbers:	14269, 2008-008315-25
Study First Received:	September 17, 2010
Last Updated:	January 18, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Finland: Finnish Medicines Agency Switzerland: Swissmedic

Keywords provided by Piramal Imaging SA:

Neoplasm
PET/CT diagnosis
PET tracer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bombesin

Gastrin-Releasing Peptide
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013