NCT04410133 (REVELATE) is a Phase 3 clinical trial of 18F fluciclovine in Brain Metastases, sponsored by Blue Earth Diagnostics.

Who is sponsoring NCT04410133?

NCT04410133 is sponsored by Blue Earth Diagnostics.

What drugs are being tested in NCT04410133?

Interventions in NCT04410133: 18F fluciclovine.

What condition does NCT04410133 study?

NCT04410133 studies Brain Metastases.

Is NCT04410133 still recruiting?

NCT04410133 is currently completed. Last updated 28 August 2025.

Are results published for NCT04410133?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-08-28 · How we verify

NCT04410133: REVELATE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases

Completed Phase 3 Results posted Last updated 28 August 2025

What this trial tests

Phase 3 trial testing 18F fluciclovine in Brain Metastases in 151 participants. Completed in 5 June 2023.

Timeline

26 October 2020

Primary endpoint
5 June 2023

5 June 2023

Quick facts

Lead sponsor	Blue Earth Diagnostics
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	151
Start date	26 October 2020
Primary completion	5 June 2023
Estimated completion	5 June 2023
Sites	19 locations across United States

Drugs / interventions tested

18F fluciclovine — full drug profile →

Conditions studied

Brain Metastases — all drugs for Brain Metastases →

Sponsor

Blue Earth Diagnostics — full company profile →

Who can join

18 and older, any sex, with Brain Metastases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level Primary · MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Subject-level PPA and NPA (equivalent to sensitivity and specificity, respectively) of 18F-fluciclovinePET in detecting recurrent brain metastases.

Group	Value	95% CI
Reader 1 - Positive Percent Agreement (PPA)	23.8	12.1 – 39.5
Reader 2 - Positive Percent Agreement (PPA)	34.1	20.1 – 50.6
Reader 3 - Positive Percent Agreement (PPA)	36.6	22.1 – 53.1
Reader 1 - Negative Percent Agreement (NPA)	82.6	74.1 – 89.2
Reader 2 - Negative Percent Agreement (NPA)	70.9	61.5 – 79.2
Reader 3 - Negative Percent Agreement (NPA)	70.9	61.5 – 79.2

Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Secondary · MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Subject-level PPV and NPV of 18F-fluciclovine PET for detecting recurrent brain metastases

Group	Value	95% CI
Reader 1 - Positive Predictive Value (PPV)	34.5	17.9 – 54.3
Reader 2 - Positive Predictive Value (PPV)	30.4	17.7 – 45.8
Reader 3 - Positive Predictive Value (PPV)	31.9	19.1 – 47.1
Reader 1 - Negative Predictive Value (NPV)	73.8	65.0 – 81.3
Reader 2 - Negative Predictive Value (NPV)	74.3	64.8 – 82.5
Reader 3 - Negative Predictive Value (NPV)	75.0	65.6 – 83.0

Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Secondary · MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

To assess lesion-level PPA \& NPA diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.

Group	Value	95% CI
Reader 1 - Positive Percent Agreement (PPA)	18.4	7.3 – 29.4
Reader 2 - Positive Percent Agreement (PPA)	28.6	15.8 – 41.4
Reader 3 - Positive Percent Agreement (PPA)	30.6	17.7 – 43.5
Reader 1 - Negative Percent Agreement (NPA)	84.1	77.4 – 90.7
Reader 2 - Negative Percent Agreement (NPA)	74.6	66.6 – 82.7
Reader 3 - Negative Percent Agreement (NPA)	73.2	65.0 – 81.4

Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Secondary · MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

To assess lesion-level PPV \& NPV diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.

Group	Value	95% CI
Reader 1 - Positive Predictive Value (PPV)	29.0	12.1 – 45.9
Reader 2 - Positive Predictive Value (PPV)	28.6	15.2 – 42.0
Reader 3 - Positive Predictive Value (PPV)	28.8	15.3 – 42.4
Reader 1 - Negative Predictive Value (NPV)	74.4	65.5 – 83.2
Reader 2 - Negative Predictive Value (NPV)	74.6	65.4 – 83.9
Reader 3 - Negative Predictive Value (NPV)	74.8	65.8 – 83.8

Subject-level Positive Percent Agreement (PPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type Secondary · MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Sub-group analyses of subject-level PPA \& NPA of fluciclovine (18F) PET, according to primary tumor type.

Melanoma

Group	Value	95% CI
Reader 1 - Positive Percent Agreement (NPA)	50.0	1.3 – 98.7
Reader 2 - Positive Percent Agreement (NPA)	50.0	1.3 – 98.7
Reader 3 - Positive Percent Agreement (NPA)	0.0	0.0 – 84.2
Reader 1 - Negative Percent Agreement (NPA)	83.3	58.6 – 96.4
Reader 2 - Negative Percent Agreement (NPA)	72.2	46.5 – 90.3
Reader 3 - Negative Percent Agreement (NPA)	66.7	41.0 – 86.7

Breast

Group	Value	95% CI
Reader 1 - Positive Percent Agreement (NPA)	10.0	0.3 – 44.5
Reader 2 - Positive Percent Agreement (NPA)	30.0	6.7 – 65.3
Reader 3 - Positive Percent Agreement (NPA)	40.0	12.2 – 73.8
Reader 1 - Negative Percent Agreement (NPA)	78.3	56.3 – 92.5
Reader 2 - Negative Percent Agreement (NPA)	65.2	42.7 – 83.6
Reader 3 - Negative Percent Agreement (NPA)	73.9	51.6 – 89.8

Lung Cancer

Group	Value	95% CI
Reader 1 - Positive Percent Agreement (NPA)	29.2	12.6 – 51.1
Reader 2 - Positive Percent Agreement (NPA)	39.1	19.7 – 61.5
Reader 3 - Positive Percent Agreement (NPA)	43.5	23.2 – 65.5
Reader 1 - Negative Percent Agreement (NPA)	85.4	72.2 – 93.9
Reader 2 - Negative Percent Agreement (NPA)	69.4	54.6 – 81.8
Reader 3 - Negative Percent Agreement (NPA)	67.3	52.5 – 80.1

Non Lung/Breast/Melanoma

Group	Value	95% CI
Reader 1 - Positive Percent Agreement (NPA)	16.7	0.4 – 64.1
Reader 2 - Positive Percent Agreement (NPA)	16.7	0.4 – 64.1
Reader 3 - Positive Percent Agreement (NPA)	16.7	0.4 – 64.1
Reader 1 - Negative Percent Agreement (NPA)	80.0	56.3 – 94.3
Reader 2 - Negative Percent Agreement (NPA)	80.0	56.3 – 94.3
Reader 3 - Negative Percent Agreement (NPA)	80.0	56.3 – 94.3

Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type Secondary · MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Sub-group analyses of subject-level PPV \& NPV of fluciclovine (18F) PET, according to primary tumor type.

Melanoma

Group	Value	95% CI
Reader 1 - Positive Predictive Value (PPV)	25.0	0.6 – 80.6
Reader 2 - Positive Predictive Value (PPV)	16.7	0.4 – 64.1
Reader 3 - Positive Predictive Value (PPV)	0.0	0.0 – 45.9
Reader 1 - Negative Predictive Value (NPV)	93.8	69.8 – 99.8
Reader 2 - Negative Predictive Value (NPV)	92.9	66.1 – 99.8
Reader 3 - Negative Predictive Value (NPV)	85.7	57.2 – 98.2

Breast

Group	Value	95% CI
Reader 1 - Positive Predictive Value (PPV)	16.7	0.4 – 64.1
Reader 2 - Positive Predictive Value (PPV)	27.3	6.0 – 61.0
Reader 3 - Positive Predictive Value (PPV)	40.0	12.2 – 73.8
Reader 1 - Negative Predictive Value (NPV)	66.7	46.0 – 83.5
Reader 2 - Negative Predictive Value (NPV)	68.2	45.1 – 86.1
Reader 3 - Negative Predictive Value (NPV)	73.9	51.6 – 89.8

Lung Cancer

Group	Value	95% CI
Reader 1 - Positive Predictive Value (PPV)	50.0	23.0 – 77.0
Reader 2 - Positive Predictive Value (PPV)	37.5	18.8 – 59.4
Reader 3 - Positive Predictive Value (PPV)	38.5	20.2 – 59.4
Reader 1 - Negative Predictive Value (NPV)	70.7	57.3 – 81.9
Reader 2 - Negative Predictive Value (NPV)	70.8	55.9 – 83.1
Reader 3 - Negative Predictive Value (NPV)	71.7	56.5 – 84.0

Non Lung/Breast/Melanoma

Group	Value	95% CI
Reader 1 - Positive Predictive Value (PPV)	20.0	0.5 – 71.6
Reader 2 - Positive Predictive Value (PPV)	20.0	0.5 – 71.6
Reader 3 - Positive Predictive Value (PPV)	20.0	0.5 – 71.6
Reader 1 - Negative Predictive Value (NPV)	76.2	52.8 – 91.8
Reader 2 - Negative Predictive Value (NPV)	76.2	52.8 – 91.8
Reader 3 - Negative Predictive Value (NPV)	76.2	52.8 – 91.8

Subject-level Positive Percent Agreement (NPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy Secondary · MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Sub-group analyses of subject-level PPA \& NPA of fluciclovine (18F) PET, according to concurrent immunotherapy.

Received Concurrent Immunotherapy

Group	Value	95% CI
Reader 1 - Positive Percent Agreement (NPA)	0.0	0.0 – 45.9
Reader 2 - Positive Percent Agreement (NPA)	16.7	0.4 – 64.1
Reader 3 - Positive Percent Agreement (NPA)	16.7	0.4 – 64.1
Reader 1 - Negative Percent Agreement (NPA)	100.0	88.4 – 100.0
Reader 2 - Negative Percent Agreement (NPA)	86.7	69.3 – 96.2
Reader 3 - Negative Percent Agreement (NPA)	90.0	73.5 – 97.9

Did Not Receive Concurrent Immunotherapy

Group	Value	95% CI
Reader 1 - Positive Percent Agreement (NPA)	27.8	14.2 – 45.2
Reader 2 - Positive Percent Agreement (NPA)	37.1	21.5 – 55.1
Reader 3 - Positive Percent Agreement (NPA)	40.0	23.9 – 57.9
Reader 1 - Negative Percent Agreement (NPA)	75.9	65.0 – 84.9
Reader 2 - Negative Percent Agreement (NPA)	65.0	53.5 – 75.3
Reader 3 - Negative Percent Agreement (NPA)	63.8	52.2 – 74.2

Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy Secondary · MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Sub-group analyses of subject-level PPV \& NPV of fluciclovine (18F) PET, according to Concurrent Immunotherapy.

Received Concurrent Immunotherapy

Group	Value	95% CI
Reader 2 - Positive Predictive Value (PPV)	20.0	0.5 – 71.6
Reader 3 - Positive Predictive Value (PPV)	25.0	0.6 – 80.6
Reader 1 - Negative Predictive Value (NPV)	83.3	67.2 – 93.6
Reader 2 - Negative Predictive Value (NPV)	83.9	66.3 – 94.6
Reader 3 - Negative Predictive Value (NPV)	84.4	67.2 – 94.7

Did Not Receive Concurrent Immunotherapy

Group	Value	95% CI
Reader 1 - Positive Predictive Value (PPV)	34.5	17.9 – 54.3
Reader 2 - Positive Predictive Value (PPV)	31.7	18.1 – 48.1
Reader 3 - Positive Predictive Value (PPV)	32.6	19.1 – 48.5
Reader 1 - Negative Predictive Value (NPV)	69.8	58.9 – 79.2
Reader 2 - Negative Predictive Value (NPV)	70.3	58.5 – 80.3
Reader 3 - Negative Predictive Value (NPV)	70.8	58.9 – 81.0

Clinical Usefulness Secondary · Follow up through 6 months after PET scan.

Number of days taken by the site to establish presence/absence of metastasis by clinical follow-up.

Group	Value	95% CI
Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan	112	77.0 – 142.0

Clinical Usefulness Secondary · Follow up through 6 months after PET scan.

Proportion of subjects with additional metastases identified on fluciclovine (18F) PET in addition to SoC brain MRI

Group	Value	95% CI
Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan	1.3	0.2 – 4.7

Clinical Usefulness Secondary · Follow up through 6 months after PET scan.

Proportion of subjects whose prospective diagnostic management plan changed following fluciclovine (18F) PET.

Group	Value	95% CI
Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan	26.5	19.7 – 34.3

Inter-reader Reproducibility Secondary · PET Scan Day 1

Pairwise comparisons of the central reads for the 3 readers (i.e. Reader 1 vs Reader 2, Reader 1 vs Reader 3, and Reader 2 vs Reader 3) at the subject-level. The percentage of results in agreement (i.e. Positive \[1st reader\] / Positive \[2nd reader\], Negative/Negative) is presented.

Reader 1 vs Reader 2

Group	Value	95% CI
Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan	86.1

Reader 1 vs Reader 3

Group	Value	95% CI
Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan	84.1

Reader 2 vs Reader 3

Group	Value	95% CI
Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan	91.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment emerging AEs were captured within 48 hours.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan

Serious: 2/151 (1%)

Deaths: 0/151

Serious adverse events (2 terms)

Reaction	System	Subjects Receiving Single …
Seizure	Nervous system disorders	—
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—

Other adverse events (16 terms — click to expand)

Reaction	System	Subjects Receiving Single …
Fatigue	General disorders	—
Dizziness	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Infusion site bruising	General disorders	—
Injection site reaction	General disorders	—
Headache	Nervous system disorders	—
Paraesthesia	Nervous system disorders	—
Seizure	Nervous system disorders	—
Vomiting	Gastrointestinal disorders	—
Hordeolum	Infections and infestations	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Insomnia	Psychiatric disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Hypertension	Vascular disorders	—

Most-reported serious reactions: Seizure, Metastases to central nervous system.

Data from ClinicalTrials.gov NCT04410133 adverse events section.

Sponsor's own description

An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in detecting recurrent brain metastases after radiation therapy

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The dilemma of radiation necrosis from diagnosis to treatment in the management of brain metastases.
Mayo ZS, Billena C, Suh JH, Lo SS, et al · · 2024 · cited 34× · PMID 38437665 · DOI 10.1093/neuonc/noad188
Investigational PET tracers in neuro-oncology-What's on the horizon? A report of the PET/RANO group.
Galldiks N, Langen KJ, Albert NL, Law I, et al · · 2022 · cited 26× · PMID 35674736 · DOI 10.1093/neuonc/noac131
Novel Mechanisms and Future Opportunities for the Management of Radiation Necrosis in Patients Treated for Brain Metastases in the Era of Immunotherapy.
Vaios EJ, Winter SF, Shih HA, Dietrich J, et al · · 2023 · cited 18× · PMID 37173897 · DOI 10.3390/cancers15092432
Multidisciplinary management strategies for recurrent brain metastasis after prior radiotherapy: An overview.
Kotecha R, La Rosa A, Brown PD, Vogelbaum MA, et al · · 2025 · cited 6× · PMID 39495010 · DOI 10.1093/neuonc/noae220
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.
Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, et al · · 2021 · cited 1× · PMID 34081125 · DOI 10.1093/neuonc/noab097
P15.11.A 18F-Fluciclovine PET/CT to distinguish radiation necrosis from tumour progression in brain metastases treated with stereotactic radiosurgery: results of a prospective pilot study
· 2022
P15.10.B A multicenter phase 3 trial in progress: diagnostic performance of18F-fluciclovine PET for the detection of recurrent brain metastases after radiation therapy (REVELATE)
· 2022
P15.13.B Role and accuracy of FET-PET in gliomas, and its significance in the differential diagnosis among progression, pseudoprogression, and response to treatments
· 2022

Verify or expand the search:

Other trials of 18F fluciclovine

Trials testing the same drug.

NCT04410367 — Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSU · Phase 2 · completed
NCT03423082 — Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer. · Phase 4 · terminated

Other recruiting trials for Brain Metastases

Currently open trials in the same condition.

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NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer · active not recruiting
NCT07053033 — Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR Be · Phase 2 · recruiting

Other Blue Earth Diagnostics trials

Trials by the same sponsor.

NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
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NCT04410367 — Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSU · Phase 2 · completed
NCT04186845 — Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer · Phase 3 · completed
NCT04186819 — Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cance · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04410133 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Blue Earth Diagnostics
Last refreshed: 28 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04410133.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04410133: REVELATE

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (2 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of 18F fluciclovine

Other recruiting trials for Brain Metastases

Other Blue Earth Diagnostics trials

Verify against primary sources