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

Primary Purpose

Diagnostic Imaging, Neoplasms

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BAY94-9392

About this trial

This is an interventional diagnostic trial for Diagnostic Imaging focused on measuring Neoplasm, PET/CT diagnosis, PET tracer

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual assessment of lesion

Secondary Outcome Measures

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

Electrocardiogram (ECG)

Blood pressure

Serum protein

Serum creatinine

Serum GOT (Glutamate-Oxalacetate-Transaminase)

Adverse events collection

Radiation doses per organ (µGy/MBq)

Higher organ dose (HT)

Doses per organ (µSv/MBq)

Effective dose (µSv/MBq)

Effective dose resulting from the total administered diagnostic activity of 300 MBq +/- 10%

Full Information

NCT ID

NCT01103310

First Posted

March 31, 2010

Last Updated

November 11, 2014

Sponsor

Life Molecular Imaging SA

1. Study Identification

Unique Protocol Identification Number

NCT01103310

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Life Molecular Imaging SA

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diagnostic Imaging, Neoplasms

Keywords

Neoplasm, PET/CT diagnosis, PET tracer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

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

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BAY94-9392

Primary Outcome Measure Information:

Title

Visual assessment of lesion

Time Frame

Day of study drug administration

Secondary Outcome Measure Information:

Title

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

Time Frame

Day of study drug administration

Title

Electrocardiogram (ECG)

Time Frame

At least twice within 2 days after treatment

Title

Blood pressure

Time Frame

At least twice within 2 days after treatment

Title

Serum protein

Time Frame

At least twice within 2 days after treatment

Title

Serum creatinine

Time Frame

At least twice within 2 days after treatment

Title

Serum GOT (Glutamate-Oxalacetate-Transaminase)

Time Frame

At least twice within 2 days after treatment

Title

Adverse events collection

Time Frame

Continuously for at least 4 days after treatment

Title

Radiation doses per organ (µGy/MBq)

Time Frame

Day of study drug administration

Title

Higher organ dose (HT)

Time Frame

Day of study drug administration

Title

Doses per organ (µSv/MBq)

Time Frame

Day of study drug administration

Title

Effective dose (µSv/MBq)

Time Frame

Day of study drug administration

Title

Effective dose resulting from the total administered diagnostic activity of 300 MBq +/- 10%

Time Frame

Day of study drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

City

München

State/Province

Bayern

ZIP/Postal Code

81675

Country

Germany

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

23232273

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.

Results Reference

background

PubMed Identifier

22893629

Citation

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.

Results Reference

background

PubMed Identifier

23568366

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.

Results Reference

background

PubMed Identifier

32694158

Citation

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.

Results Reference

derived

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

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