Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation
NCT ID: NCT01103310
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2010-04-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm 1
Cancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET/CT
BAY94-9392
Arm 2
Healthy volunteers, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY94-9392 in blood
BAY94-9392
Interventions
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BAY94-9392
Eligibility Criteria
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Inclusion Criteria
* 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
* Known sensitivity to the study drug or components of the preparation
35 Years
75 Years
ALL
Yes
Sponsors
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Life Molecular Imaging SA
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Stanford, California, United States
München, Bavaria, Germany
Seoul, , South Korea
Countries
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References
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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.
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.
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.
Park SY, Na SJ, Kumar M, Mosci C, Wardak M, Koglin N, Bullich S, Mueller A, Berndt M, Stephens AW, Cho YM, Ahn H, Chae SY, Kim HO, Moon DH, Gambhir SS, Mittra ES. Clinical Evaluation of (4S)-4-(3-[18F]Fluoropropyl)-L-glutamate (18F-FSPG) for PET/CT Imaging in Patients with Newly Diagnosed and Recurrent Prostate Cancer. Clin Cancer Res. 2020 Oct 15;26(20):5380-5387. doi: 10.1158/1078-0432.CCR-20-0644. Epub 2020 Jul 21.
Other Identifiers
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14207
Identifier Type: -
Identifier Source: org_study_id