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

NCT01297088 | Completed Phase 1

• 1 other identifier: 15146
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Diagnostic Imaging

Keywords

Proof of Mechanism; Phase I; Neoplasm; Inflammation

Outcome Measures

Primary Outcomes (5)

• BAY86-9596 lesion detection rate (overall number of lesions identified).

  up to 2 hours

• Overall image quality (poor, satisfactory, excellent; based on investigator's experience with 18F-labeled PET tracers)

  up to 2 hours

• BAY86-9596 accumulation score in identified lesions (low accumulation, high accumulation).

  up to 2 hours

• 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.

  up to 2 hours

• Comparison of BAY86-9596 accumulation with lesions identified in histology of prostate cancer.

  up to 2 hours

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: BAY86-9596

Interventions

BAY86-9596 DRUG

One single dose administration of a diagnostic agent

Arm 1

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Life Molecular Imaging SA: lead

Study Sites (2)

Unknown Facility

Singapore, 119074, Singapore

Location

Unknown Facility

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 16, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 21, 2013

Record last verified: 2013-01

Locations

SG (2)