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Completed

NCT Number: NCT01205321

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

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.

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Key information

Conditions

Diagnostic Imaging Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Turku, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bombesin (68Ga) labeled (BAY86-7548)

Drug

Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT

Primary outcomes

  1. Visual assessment of lesions

    Time frame: Day of study drug administration

Secondary outcomes

  1. Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)

    Time frame: Day of study drug administration

  2. ECG (significant abnormalities)

    Time frame: At least 3 times until one day after treatment

  3. Blood pressure

    Time frame: At least 3 times until one day after treatment

  4. Serum protein

    Time frame: At least 3 times until one day after treatment

  5. Serum creatinine

    Time frame: At least 3 times until one day after treatment

  6. Serum GOT (Glutamat-Oxalacetat-Transaminase)

    Time frame: At least 3 times until one day after treatment

  7. Adverse events collection

    Time frame: Continuously for at least 5 days after treatment

Sponsors and collaborators

Lead sponsor

Lantheus Biosciences Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 20, 2010
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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