NCT04241315 · STUDY IN CONTEXT

ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.

Full Analysis Set (FAS): The FAS for the primary analysis of the primary efficacy endpoint will include subjects exposed to OTL38 and randomized to undergo fluorescent imaging (OTL38+Imaging) who: • Were evaluated under both normal light/palpation and NIR fluorescent light imaging

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primary · POSTED

Proportion of FAS subjects with one or more primary NIR fluorescence positive lung nodules (cancerous or non-cancerous, excluding normal lung parenchyma) not detected under normal light and/or palpation

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primary · POSTED

The proportion of FAS subjects with one or more NIR fluorescence positive cancerous synchronous lesions not detected under normal light and/or palpation

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primary · POSTED

The proportion of FAS subjects with the identification of a cancerous positive margin that fluoresces within (less than or equal to) 10 mm of the surgical resection staple line

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secondary · POSTED

Sensitivity or True Positive Rate (TPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed to be cancer relative to the total number of primary nodules and synchronous lesions confirmed to be cancer.

Total number of Subjects with Evaluated Tissues

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secondary · POSTED

False Positive Rate (FPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed not to be cancer relative to the total number of fluorescent light positive primary nodules and synchronous lesions

Total number of Subjects with Evaluated Tissues

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-lung-neoplasm
nct id: NCT04241315
trial label: ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
outcome key
om-0000
source section id
NCT04241315-om-0000
source outcome index
0
endpoint
Clinically Significant Events (CSE)
endpoint definition
The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.
time origin
1 day
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Full Analysis Set (FAS): The FAS for the primary analysis of the primary efficacy endpoint will include subjects exposed to OTL38 and randomized to undergo fluorescent imaging (OTL38+Imaging) who: • Were evaluated under both normal light/palpation and NIR fluorescent light imaging
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
outcome key
om-0001
source section id
NCT04241315-om-0001
source outcome index
1
endpoint
Localization of Primary Nodule
endpoint definition
Proportion of FAS subjects with one or more primary NIR fluorescence positive lung nodules (cancerous or non-cancerous, excluding normal lung parenchyma) not detected under normal light and/or palpation
time origin
1 day
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Full Analysis Set (FAS): The FAS for the primary analysis of the primary efficacy endpoint will include subjects exposed to OTL38 and randomized to undergo fluorescent imaging (OTL38+Imaging) who: • Were evaluated under both normal light/palpation and NIR fluorescent light imaging
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
outcome key
om-0002
source section id
NCT04241315-om-0002
source outcome index
2
endpoint
Identification of Cancerous Synchronous Lesions
endpoint definition
The proportion of FAS subjects with one or more NIR fluorescence positive cancerous synchronous lesions not detected under normal light and/or palpation
time origin
1 day
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Full Analysis Set (FAS): The FAS for the primary analysis of the primary efficacy endpoint will include subjects exposed to OTL38 and randomized to undergo fluorescent imaging (OTL38+Imaging) who: • Were evaluated under both normal light/palpation and NIR fluorescent light imaging
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
outcome key
om-0003
source section id
NCT04241315-om-0003
source outcome index
3
endpoint
Positive Resection Margins
endpoint definition
The proportion of FAS subjects with the identification of a cancerous positive margin that fluoresces within (less than or equal to) 10 mm of the surgical resection staple line
time origin
1 day
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Full Analysis Set (FAS): The FAS for the primary analysis of the primary efficacy endpoint will include subjects exposed to OTL38 and randomized to undergo fluorescent imaging (OTL38+Imaging) who: • Were evaluated under both normal light/palpation and NIR fluorescent light imaging
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
outcome key
om-0004
source section id
NCT04241315-om-0004
source outcome index
4
endpoint
Sensitivity for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects
endpoint definition
Sensitivity or True Positive Rate (TPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed to be cancer relative to the total number of primary nodules and synchronous lesions confirmed to be cancer.
time origin
1 day
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Total number of Subjects with Evaluated Tissues
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
outcome key
om-0005
source section id
NCT04241315-om-0005
source outcome index
5
endpoint
False Positive Rate for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects
endpoint definition
False Positive Rate (FPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed not to be cancer relative to the total number of fluorescent light positive primary nodules and synchronous lesions
time origin
1 day
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Total number of Subjects with Evaluated Tissues
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
outcome key
om-0000
arm key
OG000
arm label
Full Analysis Set (FAS)
regimen
The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04241315-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
outcome key
om-0001
arm key
OG000
arm label
Fully Analysis Set (FAS)
regimen
The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04241315-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
outcome key
om-0002
arm key
OG000
arm label
Fully Analysis Set (FAS)
regimen
The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04241315-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
outcome key
om-0003
arm key
OG000
arm label
Fully Analysis Set (FAS)
regimen
The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04241315-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
outcome key
om-0004
arm key
OG000
arm label
Fully Analysis Set (FAS)
regimen
The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
analyzed count
89
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04241315-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
outcome key
om-0005
arm key
OG000
arm label
Fully Analysis Set (FAS)
regimen
The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
analyzed count
78
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04241315-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
harm key
EG000
source section id
NCT04241315-ae
event group key
EG000
event group label
Near-Infrared Imaging Group
serious affected
7
serious at risk
100
other affected
98
other at risk
100
frequency threshold
5
collection period
Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-lung-neoplasm
nct id
NCT04241315
harm key
EG001
source section id
NCT04241315-ae
event group key
EG001
event group label
No Imaging Group
serious affected
2
serious at risk
11
other affected
11
other at risk
11
frequency threshold
5
collection period
Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice