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
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ClinicalTrials.gov Identifier: NCT01205321 |
Recruitment Status
:
Completed
First Posted
: September 20, 2010
Last Update Posted
: January 21, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diagnostic Imaging | Drug: Bombesin (68Ga) labeled (BAY86-7548) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
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 |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | December 2011 |

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
|
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
|
- Visual assessment of lesions [ Time Frame: Day of study drug administration ]
- 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 ]

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Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205321
Finland | |
Turku, Finland, FIN-20521 | |
Germany | |
Ulm, Baden-Württemberg, Germany, 89081 | |
Switzerland | |
Zürich, Switzerland, 8091 |
Study Director: | Bayer Study Director | Bayer |
Additional Information:
Responsible Party: | Piramal Imaging SA |
ClinicalTrials.gov Identifier: | NCT01205321 History of Changes |
Other Study ID Numbers: |
14269 2008-008315-25 ( EudraCT Number ) |
First Posted: | September 20, 2010 Key Record Dates |
Last Update Posted: | January 21, 2013 |
Last Verified: | January 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 |