Efficacy and Safety


ELUCIDATE (Trial 007): Enabling Lung Cancer Identification Using Folate Receptor Targeting

Study Design

A Phase 3, randomized, single dose, open-label trial that investigated the safety and efficacy of CYTALUX® for intraoperative imaging of folate receptor positive lung lesions.

Primary Endpoint: Clinical Significant Events

Localization of
pulmonary lesion

Detection of one or more
synchronous malignant lesions

Identification of a close
resection margin


In 19% of patients, the primary lung lesion was localized, but not detected with conventional methods.
In 8% of patients, surgeons found one or more occult malignant lesions that were not previously identified.

In 38% of patients, a close resection margin (≤10mm) was identified.*

Surgeons reported changing the scope
of their procedure
in 29% of patients,
due to use of CYTALUX.

* Sarkaria IS, Martin LW, Rice DC, Blackmon SH, Slade HB, Singhal S; ELUCIDATE Study Group. Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. J Thorac Cardiovasc Surg. 2023 Mar 3:S0022-5223(23)00185-X. doi: 10.1016/j.jtcvs.2023.02.025. Epub 2023 Mar 02. PMID: 37019717.
† Based on a prespecified exploratory endpoint for the proportion of subjects for whom the surgical plan was changed based on fluorescence imaging both prior to initiation of the surgical procedure and upon re-imaging of the surgical field after surgical procedure prior to closing. (N=100, 95% CI [20.4, 38.9])

Size of lesions identified by CYTALUX and not by standard white light in Phase 3 Trial*MEDIANMINIMUM
Primary Lesions13 mm5 mm
Synchronous lesions12 mm2 mm
*as measured by local pathology
LESION depth
Depth of lesions detected by CYTALUX in Phase 3 Trial*MEDIANMAXIMUM
Detected by CYTALUX only10.1 mm27.9 mm
Detected by CYTALUX and white light2.3 mm37.7 mm
*as measured by preoperative CT/PET imaging. The depth of primary lung lesions detected by CYTALUX ranged from 0 to 38 mm from the lung surface (mean depth 6 mm).

Drug-Related Adverse Events

ELUCIDATE Phase 3 Trial

n (%)
n (%)
Subjects with at least one drug-related TEAE36 (32.1%)3 (2.7%)
Total number of drug-related TEAEs555

drug-related serious adverse events were observed in any patient dosed with CYTALUX.

n (%)
n (%)
Nausea10 (8.9%)0
Vomiting4 (3.6%)0
Intermittent hypertension3 (2.7%)1 (0.9%)

of all drug-related adverse events were mild-to-moderate.


drug-related serious adverse events were observed in any patient dosed with CYTALUX.


of all drug-related adverse events were mild-to-moderate.

TEAE = Treatment Emergent Adverse Event
N=112 study subjects infused with CYTALUX

Misinterpretation of Camera Images

Errors may occur with the use of CYTALUX during intraoperative fluorescence imaging to detect ovarian cancer and lesions in the lung, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung. Fluorescence may be seen in normal tissues including bowel, kidneys, lymph nodes, lungs, and inflamed tissue.

Speak with a representative
about CYTALUX and how to bring this technology to your OR.