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PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.

Primary Purpose

Diagnostic Imaging

Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
BAY86-9596
Sponsored by
Life Molecular Imaging SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diagnostic Imaging focused on measuring Proof of Mechanism, Phase I, Neoplasm, Inflammation

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cancer Patients

    • Patient had an Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computer tomography(CT) performed 14 days prior to treatment with BAY86-9596 for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for cancers such as

      • Colorectal cancer,
      • Breast cancer (female patients),
      • Hepatocellular carcinoma (HCC) and the cancers under colorectal cancer to hepatocellular carcinoma (HCC) are histologically confirmed (Exception, based on diagnostic criteria for the management of hepatocellular carcinoma: Histological diagnosis of hepatocelluar carcinoma is not necessary if the nodule is larger than 2 cm, has been visualized in two dynamic imaging studies and shows arterial hyperenhancement and washes out in the venous phase.)
    • Patient has prostate cancer (primary or recurrent), still shows tumor mass (primary tumor and/or lymph node metastasis and/or distant metastasis) and the primary cancer disease is histologically confirmed
    • Patient has brain metastasis (strong evidence from imaging modalities), and the primary cancer disease is histologically confirmed.
    • Patient has a primary malignant brain tumor which is either confirmed by histology, or a positive cytology of cerebrospinal fluid, or imaging modalities (such as MRI, CT) strongly support the diagnosis of brain tumor.
    • Patient has some other cancer (such as ovarian cancer, melanoma), preferably with an FDG PET/CT available, and the primary cancer is histologically confirmed.
  • Inflammation Patients

    • Patient with inflammatory disease having inflammatory focus/foci. An FDG PET/CT of the inflammation is available.
    • Patient underwent FDG PET/CT during the inflammation. The maximum interval between FDG PET/CT and examination with BAY86-9596 is 5 days, performance of both examinations on two subsequent days is recommended.

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 BAY86-9596, unstable and uncontrolled hypertension, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study. When considering hepatic function in hepatocellular cancer patients, the Child-Pugh score is applied, a score > 7 will be considered an exclusion criterion.
  • Known sensitivity to the study drug or components of the preparation
  • Drug abuse/dependence or history of recovered alcohol dependence.
  • Patient has completed participation in another clinical study involving administration of an investigational drug in the preceding 4 weeks or is participating in any other clinical trial during this study
  • Previous participation in treatment phase in this study
  • Unwillingness or inability to comply with the protocol
  • Patient fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety.
  • Patients with inflammatory disease with known tumor where images of tumor lesions may overlap with inflammatory lesions, or tumor patients with known inflammatory diseases (e.g. autoimmune diseases), where images of inflammatory lesions may overlap with tumor lesions.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

BAY86-9596 lesion detection rate (overall number of lesions identified).
Overall image quality (poor, satisfactory, excellent; based on investigator's experience with 18F-labeled PET tracers)
BAY86-9596 accumulation score in identified lesions (low accumulation, high accumulation).
Comparative score BAY86-9596 versus FDG. If an FDG PET/CT is not available (in malignant brain tumors or in brain metastasis), this comparison will be done with routine imaging modalities such as CT or MRI, or choline PET/CT.
Comparison of BAY86-9596 accumulation with lesions identified in histology of prostate cancer.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2011
Last Updated
January 18, 2013
Sponsor
Life Molecular Imaging SA
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1. Study Identification

Unique Protocol Identification Number
NCT01297088
Brief Title
PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.
Official Title
Open-label, Single Center Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 18 µg Mass Dose) for Evaluation of Biodistribution in Pathological Tissue in Patients With Cancer or Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Life Molecular Imaging SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will be conducted as an open label, single-center, single dose and biodistribution study in patients with cancer or inflammation. 56 patients will be selected among the patients undergoing the screening examination conducted within 3 weeks before drug administration. Single dose of the study drug will be administrated in a dose of 300 MBq to these patients. The follow-up period contains the end-of-study telephone interview 5-8 days following the treatment. Key measurements are the PET/CT image acquisitions within a time frame of about 2 hours after the single injection of BAY86-9596.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnostic Imaging
Keywords
Proof of Mechanism, Phase I, Neoplasm, Inflammation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BAY86-9596
Intervention Description
One single dose administration of a diagnostic agent
Primary Outcome Measure Information:
Title
BAY86-9596 lesion detection rate (overall number of lesions identified).
Time Frame
up to 2 hours
Title
Overall image quality (poor, satisfactory, excellent; based on investigator's experience with 18F-labeled PET tracers)
Time Frame
up to 2 hours
Title
BAY86-9596 accumulation score in identified lesions (low accumulation, high accumulation).
Time Frame
up to 2 hours
Title
Comparative score BAY86-9596 versus FDG. If an FDG PET/CT is not available (in malignant brain tumors or in brain metastasis), this comparison will be done with routine imaging modalities such as CT or MRI, or choline PET/CT.
Time Frame
up to 2 hours
Title
Comparison of BAY86-9596 accumulation with lesions identified in histology of prostate cancer.
Time Frame
up to 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cancer Patients Patient had an Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computer tomography(CT) performed 14 days prior to treatment with BAY86-9596 for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for cancers such as Colorectal cancer, Breast cancer (female patients), Hepatocellular carcinoma (HCC) and the cancers under colorectal cancer to hepatocellular carcinoma (HCC) are histologically confirmed (Exception, based on diagnostic criteria for the management of hepatocellular carcinoma: Histological diagnosis of hepatocelluar carcinoma is not necessary if the nodule is larger than 2 cm, has been visualized in two dynamic imaging studies and shows arterial hyperenhancement and washes out in the venous phase.) Patient has prostate cancer (primary or recurrent), still shows tumor mass (primary tumor and/or lymph node metastasis and/or distant metastasis) and the primary cancer disease is histologically confirmed Patient has brain metastasis (strong evidence from imaging modalities), and the primary cancer disease is histologically confirmed. Patient has a primary malignant brain tumor which is either confirmed by histology, or a positive cytology of cerebrospinal fluid, or imaging modalities (such as MRI, CT) strongly support the diagnosis of brain tumor. Patient has some other cancer (such as ovarian cancer, melanoma), preferably with an FDG PET/CT available, and the primary cancer is histologically confirmed. Inflammation Patients Patient with inflammatory disease having inflammatory focus/foci. An FDG PET/CT of the inflammation is available. Patient underwent FDG PET/CT during the inflammation. The maximum interval between FDG PET/CT and examination with BAY86-9596 is 5 days, performance of both examinations on two subsequent days is recommended. 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 BAY86-9596, unstable and uncontrolled hypertension, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study. When considering hepatic function in hepatocellular cancer patients, the Child-Pugh score is applied, a score > 7 will be considered an exclusion criterion. Known sensitivity to the study drug or components of the preparation Drug abuse/dependence or history of recovered alcohol dependence. Patient has completed participation in another clinical study involving administration of an investigational drug in the preceding 4 weeks or is participating in any other clinical trial during this study Previous participation in treatment phase in this study Unwillingness or inability to comply with the protocol Patient fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety. Patients with inflammatory disease with known tumor where images of tumor lesions may overlap with inflammatory lesions, or tumor patients with known inflammatory diseases (e.g. autoimmune diseases), where images of inflammatory lesions may overlap with tumor lesions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
City
Singapore
ZIP/Postal Code
169608
Country
Singapore

12. IPD Sharing Statement

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PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.

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