Brain MetastasesPhase 2PURSUENCT04410367

Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)

A Phase 2 study testing 18F fluciclovine in people with Brain Metastases, run by Blue Earth Diagnostics at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Brain Metastases
What is being tested?: 18F fluciclovine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 9 sitesUnited States
Study dates: 31 Aug 2020to 31 Dec 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Previous history of solid tumor brain metastasis of any origin
Histopathological confirmation of the primary solid tumor or a metastatic site
Previous radiation therapy of brain metastatic lesion(s)
A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for craniotomy

Who cannot join

1. Patients with a history of active hematological malignancy

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

University Hospital Cleveland
Cleveland, Ohio, 44106
Miami Cancer Institute
Miami, Florida, 33176
Yale School of Medicine
New Haven, Connecticut, 06519
Ochsner Clinic Foundation
New Orleans, Louisiana, 70131
NYU Langone Health
New York, New York, 10016
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Center for Quantitative Cancer Imaging at Huntsman Cancer Institute
Salt Lake City, Utah, 84112
John Wayne Cancer Institute at Providence St. John's Health Center
Santa Monica, California, 90404
Washington University School of Medicine Center for Clinical Imaging Research
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy

Conditions: Brain Metastases
Being tested: 18F fluciclovine
Keywords: Recurrent Brain Metastases, Diagnostic, Positron Emission Tomography (PET) Scan
Medical subject headings: Brain Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

18F fluciclovineDrug
Also called Axumin
18F fluciclovine injection, 185 MegaBecquerel (MBq) (5 Millicurie (mCi)) ± 20%, delivered as an intravenous bolus

Study groups in NCT04410367
Study group	Role	What they receive
Patients	Experimental	Single intravenous administration of 18F fluciclovine for PET Scan Receives: Drug: 18F fluciclovine

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds
Sensitivity is calculated as % of participants with positive histopathology who are classified as positive on their 18F fluciclovine PET (i.e. true positive). Each participant had one lesion, therefore results are representative of both subject and lesion level sensitivity.
Three readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. Three different thresholds of 18F fluciclovine uptake were then applied to calculate the sensitivity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. As an example, for calculating sensitivity based on the threshold of Mild or Higher Uptake, all participants with positive histopathology, classified by a reader as having mild, moderate or marked 18F fluciclovine uptake, would be categorized as true positive. This calculation was then repeated on the other two threshold categories, to produce sensitivities at different thresholds.
Measured: 60 days
Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds
Specificity is calculated as the % of participants with negative histopathology who are classified as negative on their 18F fluciclovine PET (i.e. true negative). Each participant had 1 lesion, therefore results are representative of both subject and lesion level specificity. 3 readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. 3 different thresholds of uptake were then applied to calculate the specificity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. Example, for calculating specificity based on the threshold of Moderate or Higher Uptake, all participants with negative histopath, classified by a reader as having absent or mild uptake (i.e. not classified by a reader as having moderate or marked uptake), would be categorized as true negative. This calculation was repeated on the other 2 threshold categories, to produce specificities at different thresholds
Measured: 60 days

Secondary outcomes (3)

Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake
Sensitivity calculated as %participants with positive histopath and positive on PET (i.e. true positive). Each participant had 1 lesion, results represent both subject and lesion level sensitivity. Sensitivity is calculated using positive PET classified by quantitative and dynamic measures. Quantitative measure is based on lesion standardized uptake value (SUV). Receiver Operating Characteristic (ROC) analysis of all participant lesion SUV was performed. ROC analyses was performed to select a SUV threshold for calculating sensitivity. Sensitivity calculation: participants with positive histopath and SUV = or > threshold are positive on scan. Dynamic measure: 3 readers evaluated PET scans to classify uptake pattern based on 4 categories: Type 0, Type I, Type II, Type III. Sensitivity is calculated for each type of uptake pattern (example: calculating sensitivity based on Type I pattern, participants with positive histopath, classified as Type I, would be categorized as true positive).
Measured: 60 days
Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake.
Specificity is calculated as %participants with negative histopath and negative on PET (i.e. true negative). Each participant had 1 lesion, results represent both subject and lesion level specificity. Specificity is calculated using negative PET classified by quantitative and dynamic measures. Quantitative measure is based on lesion standardized uptake value (SUV). Receiver Operating Characteristic (ROC) analysis of all participant lesion SUV was performed. ROC analyses was performed to select a SUV threshold for calculating sensitivity. Specificity calculation: participants with negative histopath, SUV < threshold are negative on scan. Dynamic measure: 3 readers evaluated PET scans to classify uptake pattern based on 4 categories: Type 0, Type I, Type II, Type III. Specificity is calculated for each type of uptake pattern (example, calculating specificity based on Type I pattern, participants with negative histopath, classified as Type I, would be categorized as true negative)
Measured: 60 days
Treatment-emergent Adverse Events
Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F fluciclovine until 1 day post-18F-fluciclovine administration.
Measured: From the time of administration of 18F fluciclovine until 1 day post-18F-fluciclovine administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 202031 Dec 2021

First posted1 Jun 2020
Study start31 Aug 2020
Primary completion31 Dec 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Brain MetastasesStudies 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 2
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Model description: Positron Emission Tomography (PET) Imaging study
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04410367
Sponsor's protocol ID: BED-FLC-219
Acronym: PURSUE
Status last verified: Jul 2025
First submitted: 27 May 2020
Last updated: 20 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.
PubMed 34081125

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy
ClinicalTrials.gov ID: NCT04410367
Acronym / sponsor ID: PURSUE / BED-FLC-219
Conditions: Brain Metastases
Keywords: Recurrent Brain Metastases, Diagnostic, Positron Emission Tomography (PET) Scan
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Blue Earth DiagnosticsIndustry (pharma, biotech, devices)
Collaborators: Precision For Medicine
Study start: 31 Aug 2020 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 1 Jun 2020 (actual)
Results: Posted 1 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Positron Emission Tomography (PET) Imaging study

Arm	Type	Receives
Patients	Experimental	Drug: 18F fluciclovineSingle intravenous administration of 18F fluciclovine for PET Scan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Previous history of solid tumor brain metastasis of any origin
Histopathological confirmation of the primary solid tumor or a metastatic site
Previous radiation therapy of brain metastatic lesion(s)
A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis

Key exclusion criteria (1 listed)

1. Patients with a history of active hematological malignancy

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 fluciclovineAlso: Axumin18F fluciclovine injection, 185 MegaBecquerel (MBq) (5 Millicurie (mCi)) ± 20%, delivered as an intravenous bolus	Drug	Patients

Primary outcome

Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds
Time frame: 60 days
Sensitivity is calculated as % of participants with positive histopathology who are classified as positive on their 18F fluciclovine PET (i.e. true positive). Each participant had one lesion, therefore results are representative of both subject and lesion level sensitivity. Three readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. Three different thresholds of 18F fluciclovine uptake were then applied to calculate the sensitivity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. As an example, for calculating sensitivity based on the threshold of Mild or Higher Uptake, all participants with positive histopathology, classified by a reader as having mild, moderate or marked 18F fluciclovine uptake, would be categorized as true positive. This calculation was then repeated on the other two threshold categories, to produce sensitivities at different thresholds.
Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds
Time frame: 60 days
Specificity is calculated as the % of participants with negative histopathology who are classified as negative on their 18F fluciclovine PET (i.e. true negative). Each participant had 1 lesion, therefore results are representative of both subject and lesion level specificity. 3 readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. 3 different thresholds of uptake were then applied to calculate the specificity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. Example, for calculating specificity based on the threshold of Moderate or Higher Uptake, all participants with negative histopath, classified by a reader as having absent or mild uptake (i.e. not classified by a reader as having moderate or marked uptake), would be categorized as true negative. This calculation was repeated on the other 2 threshold categories, to produce specificities at different thresholds

3 secondary outcomes

Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake
Time frame: 60 days
Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake.
Time frame: 60 days
Treatment-emergent Adverse Events
Time frame: From the time of administration of 18F fluciclovine until 1 day post-18F-fluciclovine administration.

Results and safety

Results posted to the registry on 1 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
18F-Fluciclovine Injection	23	23

Primary outcome: Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds

Time frame: 60 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	18F-Fluciclovine Injection n = 10
Mild or Higher Uptake = Positive : Central Reader 1	100 (69.2 to 100)
Mild or Higher Uptake = Positive : Central Reader 2	100 (69.2 to 100)
Mild or Higher Uptake = Positive : Central Reader 3	100 (69.2 to 100)
Moderate or Higher Uptake = Positive : Central Reader 1	100 (69.2 to 100)
Moderate or Higher Uptake = Positive : Central Reader 2	100 (69.2 to 100)
Moderate or Higher Uptake = Positive : Central Reader 3	90 (55.5 to 99.8)
Marked Uptake = Positive : Central Reader 1	80 (44.4 to 97.5)
Marked Uptake = Positive : Central Reader 2	40 (12.2 to 73.8)

Population analysed: Sensitivity analysis (%) based on 10 subjects with positive lesions per standard of truth (central histopathological analysis).

Primary outcome: Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds

Time frame: 60 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	18F-Fluciclovine Injection n = 13
Mild or Higher Uptake = Positive : Central Reader 1	0 (0.0 to 24.7)
Mild or Higher Uptake = Positive : Central Reader 2	0 (0.0 to 24.7)
Mild or Higher Uptake = Positive : Central Reader 3	0 (0.0 to 24.7)
Moderate or Higher Uptake = Positive : Central Reader 1	38.5 (13.9 to 68.4)
Moderate or Higher Uptake = Positive : Central Reader 2	30.8 (9.1 to 61.4)
Moderate or Higher Uptake = Positive : Central Reader 3	46.2 (19.2 to 74.9)
Marked Uptake = Positive : Central Reader 1	92.3 (64.0 to 99.8)
Marked Uptake = Positive : Central Reader 2	100 (75.3 to 100.0)

Population analysed: Specificity analysis (%) based on 13 subjects with negative lesions per standard of truth (central histopathological analysis).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety was assessed from the time of 18F-fluciclovine administration until 1 day post18Ffluciclovine administration based on reported adverse events (AEs) and serious adverse events (SAEs); treatment emergent adverse events (TEAE).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
18F-Fluciclovine Injection	0 of 23 (0%)	1 of 23 (4.3%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34081125Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.
Individual participant dataSharing planned: No

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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.

Eugene Teoh, MD study director

Blue Earth Diagnostics

Rupesh Kotecha, MD principal investigator

Miami Cancer Institute

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 18F fluciclovine in people with Brain Metastases, run by Blue Earth Diagnostics at 9 sites 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds (time frame: 60 days). The study lists 2 primary outcomes in all. 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 NCT04410367, 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 20 Jul 2025.