PET/CT (Positron Emission Tomography/Computed Tomography) Imaging for Safety and Tolerability and Diagnostic Performance of BAY1075553 in Patients With Prostate Cancer and Healthy Volunteers

Diagnostic Imaging Clinical Trial

Official title:

Open-label, Multi Center PET/CT Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 18F Labeled PET Tracer BAY1075553 Following a Single Intravenous Administration of 300 MBq 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: NCT01287845
• Other study ID #: 15117
• Secondary ID: 2010-022031-11
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2011
• Last updated: January 18, 2013
• Start date: February 2011
• Est. completion date: November 2011

Study information

• Verified date: January 2013
• Source: Piramal Imaging SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

PET/CT imaging study for evaluation of safety and tolerability and diagnostic performance of BAY1075553 in patients with prostate cancer and in healthy volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Part 1: Healthy volunteers only

-- Males = 40 years of age

• Part 2: Prostate cancer patients

• Males = 18 years of age

• Serum PSA (Prostate-Specific Antigen) value above normal.

• Patients had an MRI and/or a positive [11C] - or [18F] -choline PET/CT for primary diagnosis (Note: MRI and [11C]-or [18F]-choline PET/CT are optional for primary prostate cancer patients) or recurrence detection of prostate cancer and the primary cancer disease (adenocarcinoma) is histologically confirmed

• Patients with primary prostate cancer have to be scheduled for prostatectomy

• In patients with primary prostate cancer, histopathological evaluation has to show an adenocarcinoma with a Gleason score of 3 + 3 or higher in at least two biopsies at any location in the prostate

• Patients with advanced primary or recurrent prostate cancer and a high likelihood to display lymph node metastasis, ideally scheduled for explorative pelvic lymphadenectomy, are to be preferably included

• Part 3: Prostate cancer patients -- The criteria for eligibility of part 3 are identical to the ones of part 2. Except it is now no longer a preference but mandatory to only enrol patients with a presumably high likelihood of metastatic disease, especially lymph node metastasis.

Exclusion Criteria:

• Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY1075553, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study

• Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period

• Active inflammatory bowel disease within the last 6 months

• Acute prostatitis requiring medical treatment within the last 6 months

• A non-urologic bacterial infection requiring active treatment with antibiotics within 3 months

• Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years

• Patients with primary prostate cancer only: androgen ablation within 3 months before planned treatment

• Subject fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diagnostic Imaging
• Prostatic Neoplasms

Intervention

Drug:
• BAY1075553
Cancer patients, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1
• BAY1075553
Healthy volunteers for dosimetry, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Piramal Imaging SA

Countries where clinical trial is conducted

United States,  Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety parameters, for example laboratory and electrocardiogram abnormalities		Day 2	Yes
Primary	Effective radiation dose given in mSv (milliSievert) in healthy volunteers		Day 1	No
Secondary	Overall lesion detection rate		Day 1	No
Secondary	Lesion detection rate in comparison to histology, where available (cancer lesion detection rate)		Day 1	No
Secondary	Lesion detection rate in comparison to MRI (Magnetic Resonance Imaging) and/or [11C] (11Carbon)- or [18F] (18Fluor)-choline PET/CT (whenever available)		Day 1	No
Secondary	Accumulation score in all lesions identified with BAY1075553		Day 1	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.