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

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

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.

Study Overview

• Status: Completed
• Conditions: Diagnostic Imaging
• Intervention / Treatment: Drug: Bombesin (68Ga) labeled (BAY86-7548); Drug: Bombesin (68Ga) labeled (BAY86-7548)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, FIN-20521
• Germany
  • Baden-Württemberg
    • Ulm, Baden-Württemberg, Germany, 89081
• Switzerland
  • Zürich, Switzerland, 8091

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
Experimental: Arm 2	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual assessment of lesions	Day of study drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Serum GOT (Glutamat-Oxalacetat-Transaminase)	At least 3 times until one day after treatment
Adverse events collection	Continuously for at least 5 days after treatment

Collaborators and Investigators

• Sponsor: Life Molecular Imaging SA

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 17, 2010
• First Submitted That Met QC Criteria: September 17, 2010
• First Posted (Estimate): September 20, 2010

Study Record Updates

• Last Update Posted (Estimate): January 21, 2013
• Last Update Submitted That Met QC Criteria: January 18, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Neoplasm; PET/CT diagnosis; PET tracer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Bombesin; Gastrin-Releasing Peptide
• Other Study ID Numbers: 14269 (Other Identifier: City of Hope Comprehensive Cancer Center); 2008-008315-25 (EudraCT Number)