A Phase 2 Open-label Study to Evaluate the Safety and Efficacy of VGT-309 a Tumor-Targeted Activatable Fluorescent Imaging Agent to Identify Cancer in Subjects Undergoing Lung Cancer Surgery
Recruiting
99 years or below
All
Phase
2
40 participants needed
1 Location
Brief description of study
To evaluate the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of VGT-309 to detect
cancer utilizing near-infrared (NIR) fluorescence and histopathology results. 1. Sensitivity: defined as the probability that the tissue fluoresces
when it is cancer, as confirmed by histology (TP/(TP+FN))
2. Specificity: defined as the probability that the tissue does not
fluoresce when it is not cancerous as confirmed by histology
(TN/(TN+FP))
3. Positive predictive value (PPV): defined as the probability that
a tissue sample contains cancer on histologic exam if it
fluoresces (TP/(TP+FP))
4. Negative predictive value (NPV): defined as the probability
that the tissue sample does not contain cancer on histologic
exam if it does not fluoresce (TN/(TN+FN)) For each of the defined Clinically Significant Events:
A. Number of pulmonary nodules visualized using VGT-309 NIR
imaging and confirmed histologically that would not otherwise
be found by conventional modalities available to the surgeon.
B. Number of subjects where at least one synchronous lesion is
identified with VGT-309 NIR imaging, but not with
conventional modalities available to the surgeon (white light,
palpation, and/or pre-operative imaging), and it proves to be
histologically cancer.
C. Number of subjects where at least one positive margin is
identified by VGT-309 NIR imaging and pathology
demonstrates cancer cells within 5 mm of the margin.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: 99 years or below
-
Gender: All
Updated on
11 May 2022.
Study ID: 850893