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 Intervention Model: Parallel Assignment Masking: None (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:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Diagnostic Imaging

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 ]

Secondary Outcome Measures:

Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs) [ Time Frame: Day of study drug administration ]
ECG (significant abnormalities) [ Time Frame: At least 3 times until one day after treatment ]
Blood pressure [ Time Frame: At least 3 times until one day after treatment ]
Serum protein [ Time Frame: At least 3 times until one day after treatment ]
Serum creatinine [ Time Frame: At least 3 times until one day after treatment ]
Serum GOT (Glutamat-Oxalacetat-Transaminase) [ Time Frame: At least 3 times until one day after treatment ]
Adverse events collection [ Time Frame: Continuously for at least 5 days after treatment ]


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 (Adult, Senior)
Sexes 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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Responsible Party:	Piramal Imaging SA
ClinicalTrials.gov Identifier:	NCT01205321 History of Changes
Other Study ID Numbers:	14269 2008-008315-25 ( EudraCT Number )
Study First Received:	September 17, 2010
Last Updated:	January 18, 2013

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 Physiological Effects of Drugs Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 18, 2017