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

Diagnostic Imaging Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205321
• Other study ID #: 14269
• Secondary ID: 2008-008315-25
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2010
• Last updated: January 18, 2013
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Piramal Imaging SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFinland: Finnish Medicines AgencySwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diagnostic Imaging

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Piramal Imaging SA

Countries where clinical trial is conducted

Finland,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual assessment of lesions		Day of study drug administration	No
Secondary	Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)		Day of study drug administration	No
Secondary	ECG (significant abnormalities)		At least 3 times until one day after treatment	Yes
Secondary	Blood pressure		At least 3 times until one day after treatment	Yes
Secondary	Serum protein		At least 3 times until one day after treatment	Yes
Secondary	Serum creatinine		At least 3 times until one day after treatment	Yes
Secondary	Serum GOT (Glutamat-Oxalacetat-Transaminase)		At least 3 times until one day after treatment	Yes
Secondary	Adverse events collection		Continuously for at least 5 days after treatment	Yes

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