Multiinstitutional Phase 2 Clinical Trial of Intraoperative Molecular Imaging of Lung Cancer

• Published in: The Annals of thoracic surgery Vol. 112; no. 4; pp. 1150 - 1159
• Main Authors: Gangadharan, Sidhu, Sarkaria, Inderpal N., Rice, David, Murthy, Sudish, Braun, Jerry, Kucharczuk, John, Predina, Jarrod, Singhal, Sunil
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01-10-2021
• Subjects: Adenocarcinoma of Lung - diagnostic imaging; Adenocarcinoma of Lung - surgery; Adult; Aged; Aged, 80 and over; Female; Humans; Intraoperative Care; Lung - diagnostic imaging; Lung - pathology; Lung - surgery; Lung Neoplasms - diagnostic imaging; Lung Neoplasms - surgery; Male; Middle Aged; Molecular Imaging - methods; Tomography, X-Ray Computed
• ISSN: 0003-4975; 1552-6259
• DOI: 10.1016/j.athoracsur.2020.09.037

Intraoperative molecular imaging (IMI) may improve surgical outcomes during pulmonary resection for lung cancer. A multiinstitutional phase 2 IMI clinical trial was conducted using a near-infrared, folate receptor–targeted contrast agent for lung adenocarcinomas, OTL38. The primary goal was to determine whether OTL38 improved surgeons’ ability to identify difficult to find nodules, occult cancers, and positive margins.
Patients with lung nodules received OTL38 (0.025 mg/kg) preoperatively. Patients had IMI sequentially during lung inspection, tumor resection, and margin check. Efficacy was evaluated by occurrence of clinically significant events, occurrences that caused the surgeon to modify the operation or upstage the patient’s cancer. Safety was assessed for a single intravenous dose of OTL38.
Of 110 patients recruited, 92 were eligible for analysis. During lung inspection, IMI found 24 additional nodules, 9 (10%) of which were cancers that had not been known preoperatively. During tumor resection, IMI located 11 (12%) lesions that the surgeon could not find. During the margin check, IMI revealed 8 positive margins (9%) that the surgeon thought were negative. Benefits of IMI were pronounced in patients undergoing sublobar pulmonary resections and in patients with ground-glass opacities. There were no serious adverse events. All surgeons felt comfortable with the procedures by 10 cases.
In this phase 2 clinical trial, IMI improved outcomes for 26% of patients. A randomized, multiinstitutional phase 3 clinical trial is underway.