At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
pegsitacianine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Single-Dose, Open-Label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies, in Patients Undergoing Routine Surgery
In Brief
A Phase 2 clinical trial evaluating pegsitacianine and Tumor resection surgery for Lung Cancer. Completed, enrolled 24 participants across 2 sites.
Detailed Summary
This Phase 2 study is an open-label, single-arm trial where each patient is his/her own "intrapatient" control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedSep 2021
Enrollment StartApr 2022
Primary CompletionAug 2022
TodayJul 2026
First PostedSep 17, 2021
Enrollment StartApr 13, 2022
Primary CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.8 years ago
Interventions
pegsitacianinedrug
An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
Tumor resection surgeryprocedure
Standard of care surgical removal of cancerous lung lesion