Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation

Neoplasms Clinical Trial

Official title:

Open-label, Multi Center Study for an Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 100 µg Total Quantity) in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability, Pharmacokinetics, and Diagnostic Performance of the Tracer in PET/CT in Cancer Patients or Patients With Inflammation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103310
• Other study ID #: 14207
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2010
• Last updated: November 11, 2014
• Start date: April 2010
• Est. completion date: August 2011

Study information

• Verified date: November 2014
• Source: Piramal Imaging SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesKorea: Food and Drug Administration
• 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 BAY94-9392 in patients with cancer or inflammation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

Inclusion criteria:

In Germany Healthy volunteers

• Males/females = 50 and = 65 years Patients

• Males/females = 35 and = 75 years

• histologically confirmed diagnosis of non small cell lung cancer or adenocarcinoma of the breast with a positive FDG-PET or

• patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or

• inflammation with a positive FDG-PET

In Korea Patients

• Males/females = 35 and = 75 years

• histologically confirmed diagnosis of non small cell lung cancer, adenocarcinoma of the breast or hepatocellular cancer with a positive FDG-PET or

• patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or

• inflammation (positive FDG-PET mandatory, could be also done as screening examination)

Exclusion criteria:

• Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY 94-9392, 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: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diagnostic Imaging
• Neoplasms

Intervention

Drug:
• BAY94-9392

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Piramal Imaging SA

Countries where clinical trial is conducted

United States,  Germany,  Korea, Republic of, 

References & Publications (3)

Baek S, Choi CM, Ahn SH, Lee JW, Gong G, Ryu JS, Oh SJ, Bacher-Stier C, Fels L, Koglin N, Hultsch C, Schatz CA, Dinkelborg LM, Mittra ES, Gambhir SS, Moon DH. Exploratory clinical trial of (4S)-4-(3-[18F]fluoropropyl)-L-glutamate for imaging xC- transporter using positron emission tomography in patients with non-small cell lung or breast cancer. Clin Cancer Res. 2012 Oct 1;18(19):5427-37. doi: 10.1158/1078-0432.CCR-12-0214. Epub 2012 Aug 14. — View Citation

Baek S, Mueller A, Lim YS, Lee HC, Lee YJ, Gong G, Kim JS, Ryu JS, Oh SJ, Lee SJ, Bacher-Stier C, Fels L, Koglin N, Schatz CA, Dinkelborg LM, Moon DH. (4S)-4-(3-18F-fluoropropyl)-L-glutamate for imaging of xC transporter activity in hepatocellular carcinoma using PET: preclinical and exploratory clinical studies. J Nucl Med. 2013 Jan;54(1):117-23. doi: 10.2967/jnumed.112.108704. Epub 2012 Dec 11. — View Citation

Smolarz K, Krause BJ, Graner FP, Wagner FM, Hultsch C, Bacher-Stier C, Sparks RB, Ramsay S, Fels LM, Dinkelborg LM, Schwaiger M. (S)-4-(3-18F-fluoropropyl)-L-glutamic acid: an 18F-labeled tumor-specific probe for PET/CT imaging--dosimetry. J Nucl Med. 2013 Jun;54(6):861-6. doi: 10.2967/jnumed.112.112581. Epub 2013 Apr 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual assessment of lesion		Day of study drug administration	No
Secondary	Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs)		Day of study drug administration	No
Secondary	Electrocardiogram (ECG)		At least twice within 2 days after treatment	Yes
Secondary	Blood pressure		At least twice within 2 days after treatment	Yes
Secondary	Serum protein		At least twice within 2 days after treatment	Yes
Secondary	Serum creatinine		At least twice within 2 days after treatment	Yes
Secondary	Serum GOT (Glutamate-Oxalacetate-Transaminase)		At least twice within 2 days after treatment	Yes
Secondary	Adverse events collection		Continuously for at least 4 days after treatment	Yes
Secondary	Radiation doses per organ (µGy/MBq)		Day of study drug administration	No
Secondary	Higher organ dose (HT)		Day of study drug administration	No
Secondary	Doses per organ (µSv/MBq)		Day of study drug administration	No
Secondary	Effective dose (µSv/MBq)		Day of study drug administration	No
Secondary	Effective dose resulting from the total administered diagnostic activity of 300 MBq +/- 10%		Day of study drug administration	No

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