PET Imaging of Intracranial Cancers With 18F-FSPG

August 31, 2016 updated by: Life Molecular Imaging SA

An Open-Label Study of the Efficacy of 18F-FSPG PET/CT in Subjects With Intracranial Cancers

The aim of this study is to explore the efficacy of 18F-FSPG in the detection of primary or metastatic brain cancer lesions confirmed by a standard of truth, preferably histology. This is a single center, open labelled, non-randomized study. A total of 30 subjects with brain tumor or brain metastases will be enrolled. All different stages of malignancies will be recruited, including those with different types of pathologies and grades, and newly diagnosed or recurrent disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Subjects with various types and grades of primary brain tumors or brain metastasis will be recruited. The brain tumor needs to be either histologically or clinically confirmed. 18F-FSPG will be injected intravenously into the subjects, and PET/CT imaging performed. Images will be assessed visually and quantitatively.

Available tumor specimens will be analyzed by immunohistochemistry (IHC) for example for expression of components of the system xc- and associated biomarkers.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent
  2. Participant must be able to complete a PET/CT scan and MRI without the use of sedation

  3. Participant has

    • a primary brain tumor that has been histologically confirmed
    • OR confirmed or suspected recurrent brain cancer or brain metastasis for which the primary tumor has been histologically confirmed,
    • OR a brain lesion that is concerning for malignancy for which histopathological confirmation is anticipated following enrollment (e.g., biopsy or surgical resection of the tumor is scheduled)
    • OR a suspected low-grade brain tumor, where confirmation is based upon a combination of other imaging (e.g. PET/CT, MRI, diagnostic CT) and clinical assessment.
    • All pathology specimens must be within 1 year of the planned 18F-FSPG PET/CT scan.
  4. The time interval between 18F-FSPG PET/CT and other imaging (including other PET/CTs, MRI or diagnostic CT) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options)
  5. Karnofsky Performance Status Scale of 60 or higher OR an ECOG Performance Status of 0-2.
  6. No clinically relevant deviations in renal function (Serum Creatinine > Grade 2 CTCAE v4.0.). Maximal interval between confirmation and injection of 18F-FSPG is one week.
  7. No chemotherapy, radiotherapy, or immune/biologic therapy scheduled or performed between other imaging (PET/CTs, MRI, or diagnostic CTs) and18F-FSPG PET/CT.

Exclusion Criteria:

  1. Patient is scheduled for brain surgery and/or another invasive procedure within the time period of one month prior to 18F-FSPG administration. Minimally invasive needle biopsies are allowed.
  2. Known hypersensitivity to the study drug or components of the preparation

  3. Patient has completed participation in another clinical study involving administration of an investigational agent in the preceding 4 weeks. However, participation in clinical studies involving other investigational PET or SPECT tracers will not be excluded if in the opinion of the Investigator:

    • evaluation of 18F-FSPG safety and tolerability will not be confounded by the other investigational PET or SPECT tracer
    • a minimum of two days (or longer as necessary based on radiological half-life) have elapsed between investigational PET or SPECT tracer administrations to allow acceptable clearance of the tracer
    • the investigational PET or SPECT tracer administration was well tolerated by the patient.
  4. Investigator precludes participation for scientific reasons, for reasons of compliance (e.g., concurrent disease which could compromise the subject's study completion), or for reasons of the patient's safety

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
18F-FSPG will be administered to 30 patients with brain tumors or brain metastases.
Drug: 18F-FSPG
18F-FSPG is a novel F18-labelled, radiopharmaceutical agent for PET imaging. It is administered intravenously at a dose of 300 MBq (8.1mCi ± 10%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Location and number of lesions and their location as detected by 18F-FSPG uptake above background in the brain of each study subject following visual inspection of the 18F-FSPG PET/CT scans
Time Frame: 0-75 min
0-75 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Location and number of lesions detected in the whole body following visual inspection of the 18F-FSPG PET/CT scans
Time Frame: 0-75 min
0-75 min
Location and number of lesions detected in the brain and whole body following visual inspection of the CT, MR or other available PET (e.g. 18F-FDG, 18F-FLT, etc.).
Time Frame: <4 weeks from FSPG PET/CT scan
<4 weeks from FSPG PET/CT scan
Lesion size measured by means of ROIs drawn on (contrast-enhanced) MR or CT.
Time Frame: <4 weeks from FSPG PET/CT scan
<4 weeks from FSPG PET/CT scan
18F-FSPG standardized uptake value (SUV) measured in each detected lesion and in the background (region without lesion).
Time Frame: 0-75 min
0-75 min
SUV measured in each detected lesion and in the background using other available PET tracers (e.g. 18F-FDG, 18F-FLT, etc.).
Time Frame: < 4 weeks from FSPG PET/CT scan
< 4 weeks from FSPG PET/CT scan
Determination of FSPG PET/CT image quality based on visual inspection.
Time Frame: 0-75 min
0-75 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Life Molecular Imaging SA

Investigators

  • Study Director: Norman Koglin, PhD, Life Molecular Imaging SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSPG010114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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