Brain CancerPhase 1NCT02370563
PET Imaging of Intracranial Cancers With 18F-FSPG
A Phase 1 study testing 18F-FSPG in people with Brain Cancer, run by Lantheus Biosciences Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer
- What is being tested?
- 18F-FSPG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Cancer
- Being tested
- 18F-FSPG
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FSPGDrug
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%).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 18F-FSPG will be administered to 30 patients with brain tumors or brain metastases. Receives: Drug: 18F-FSPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-75 min
Secondary outcomes (6)
Location and number of lesions detected in the whole body following visual inspection of the 18F-FSPG PET/CT scans
Measured: 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.).
Measured: <4 weeks from FSPG PET/CT scan
Lesion size measured by means of ROIs drawn on (contrast-enhanced) MR or CT.
Measured: <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).
Measured: 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.).
Measured: < 4 weeks from FSPG PET/CT scan
Determination of FSPG PET/CT image quality based on visual inspection.
Measured: 0-75 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Biosciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Norman Koglin, PhD, Study director, Lantheus Biosciences Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370563
- Sponsor's protocol ID
- FSPG010114
- Status last verified
- Aug 2016
- First submitted
- 18 Feb 2015
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35191738
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of the Efficacy of 18F-FSPG PET/CT in Subjects With Intracranial Cancers
- ClinicalTrials.gov ID
- NCT02370563
- Acronym / sponsor ID
- FSPG010114
- Conditions
- Brain Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Lantheus Biosciences Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: 18F-FSPG18F-FSPG will be administered to 30 patients with brain tumors or brain metastases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent
- Participant must be able to complete a PET/CT scan and MRI without the use of sedation
- Participant has
- 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.
Key exclusion criteria (7 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FSPG18F-FSPG is a novel F18-labelled, radiopharmaceutical agent for PET imaging. It is administered intravenously at a dose of 300 MBq (8.1mCi ± 10%). | Drug | Arm 1 |
Primary outcome
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
6 secondary outcomes
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
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
Lesion size measured by means of ROIs drawn on (contrast-enhanced) MR or CT.
Time frame: <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
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
Determination of FSPG PET/CT image quality based on visual inspection.
Time frame: 0-75 min
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Derived from this study: PubMed 35191738Wardak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman Koglin, PhD study director
Lantheus Biosciences Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-FSPG in people with Brain Cancer, run by Lantheus Biosciences Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02370563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.