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

NCT01103310 | Completed Phase 1

• 1 other identifier: 14207
• Study Type: interventional
• Target: 46
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Diagnostic Imaging; Neoplasms

Keywords

Neoplasm; PET/CT diagnosis; PET tracer

Outcome Measures

Primary Outcomes (1)

• Visual assessment of lesion

  Day of study drug administration

Secondary Outcomes (12)

• Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs)

  Day of study drug administration

• Electrocardiogram (ECG)

  At least twice within 2 days after treatment

• Blood pressure

  At least twice within 2 days after treatment

• Serum protein

  At least twice within 2 days after treatment

• Serum creatinine

  At least twice within 2 days after treatment

Study Arms (2)

Arm 1

EXPERIMENTAL

Cancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET/CT

Drug: BAY94-9392

Arm 2

EXPERIMENTAL

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

Drug: BAY94-9392

Interventions

BAY94-9392 DRUG

Arm 1; Arm 2

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Life Molecular Imaging SA: lead

Study Sites (3)

Unknown Facility

Stanford, California, 94305, United States

Location

Unknown Facility

München, Bavaria, 81675, Germany

Location

Unknown Facility

Seoul, 138-736, South Korea

Location

Related Publications (4)

• 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.

  PMID: 23232273 BACKGROUND

• 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.

  PMID: 22893629 BACKGROUND

• 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.

  PMID: 23568366 BACKGROUND

• 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.

  PMID: 32694158 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 14, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

KR (1); DE (1); US (1)