Back to results

PET Imaging of Intracranial Cancers With 18F-FSPG

Primary Purpose

Brain Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

18F-FSPG

About this trial

This is an interventional diagnostic trial for Brain Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent
Participant must be able to complete a PET/CT scan and MRI without the use of sedation
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.
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)
Karnofsky Performance Status Scale of 60 or higher OR an ECOG Performance Status of 0-2.
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.
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:

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.
Known hypersensitivity to the study drug or components of the preparation
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.
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

Sites / Locations

Stanford University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

18F-FSPG will be administered to 30 patients with brain tumors or brain metastases.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Location and number of lesions detected in the whole body following visual inspection of the 18F-FSPG PET/CT scans

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.).

Lesion size measured by means of ROIs drawn on (contrast-enhanced) MR or CT.

18F-FSPG standardized uptake value (SUV) measured in each detected lesion and in the background (region without lesion).

SUV measured in each detected lesion and in the background using other available PET tracers (e.g. 18F-FDG, 18F-FLT, etc.).

Determination of FSPG PET/CT image quality based on visual inspection.

Full Information

NCT ID

NCT02370563

First Posted

February 18, 2015

Last Updated

August 31, 2016

Sponsor

Life Molecular Imaging SA

1. Study Identification

Unique Protocol Identification Number

NCT02370563

Brief Title

PET Imaging of Intracranial Cancers With 18F-FSPG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Terminated

Why Stopped

Business decision

Study Start Date

November 2014 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (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

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.

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.

6. Conditions and Keywords

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

Brain Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

18F-FSPG will be administered to 30 patients with brain tumors or brain metastases.

Intervention Type

Drug

Intervention Name(s)

18F-FSPG

Intervention Description

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%).

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Lesion size measured by means of ROIs drawn on (contrast-enhanced) MR or CT.

Time Frame

<4 weeks from FSPG PET/CT scan

Title

18F-FSPG standardized uptake value (SUV) measured in each detected lesion and in the background (region without lesion).

Time Frame

0-75 min

Title

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

Title

Determination of FSPG PET/CT image quality based on visual inspection.

Time Frame

0-75 min

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent Participant must be able to complete a PET/CT scan and MRI without the use of sedation 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. 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) Karnofsky Performance Status Scale of 60 or higher OR an ECOG Performance Status of 0-2. 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. 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: 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. Known hypersensitivity to the study drug or components of the preparation 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Norman Koglin, PhD

Organizational Affiliation

Life Molecular Imaging SA

Official's Role

Study Director

Facility Information:

Facility Name

Stanford University Medical Center

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35191738

Citation

Wardak M, Sonni I, Fan AP, Minamimoto R, Jamali M, Hatami N, Zaharchuk G, Fischbein N, Nagpal S, Li G, Koglin N, Berndt M, Bullich S, Stephens AW, Dinkelborg LM, Abel T, Manning HC, Rosenberg J, Chin FT, Gambhir SS, Mittra ES. 18F-FSPG PET/CT Imaging of System xC- Transporter Activity in Patients with Primary and Metastatic Brain Tumors. Radiology. 2022 Jun;303(3):620-631. doi: 10.1148/radiol.203296. Epub 2022 Feb 22.

Results Reference

derived

Learn more about this trial

PET Imaging of Intracranial Cancers With 18F-FSPG

We'll reach out to this number within 24 hrs