Table 1 Registered clinical studies using nano-sized particles for image-guided surgery
Study title | Nanoparticle (NP) | ClinicalTrials.gov identifier (phase) | Commentary |
|---|---|---|---|
Potential Role for Carbon Nanoparticles to Guide Central Neck Dissection in Patients with Papillary Thyroid Cancer | Carbon NPs | NCT02724176 | In contrast to the methylene blue approach, carbon nanoparticles (CNs) can adequately predict thyroid microcarcinoma patients' lymph node (LN) status and retain the durability of sentinel LN imaging. The CN technique makes it easier to identify and select patients who would most likely benefit from cervical LN dissection [86]. Colorectal cancer lymph nodes can be more easily found using tracers like activated CNs suspension in vivo [87] |
Effect of Carbon nanoparticle suspension injection vs ICG in Lymph Node Tracing During Gastrectomy (FUTURE-01) | Carbon NPs | NCT05229874 | With the fluorescence imaging feature of the Da Vinci robot surgery XI system, indocyanine green lymph node tracking navigation technology can be used throughout the procedure. Furthermore, the equipment has no impact on the lymph node tracking effect of the injection of nanocarbon suspension. The Da Vinci robot's flexible mechanical arm and the use of lymph node tracing technology increase the thoroughness of the lymph node dissection during gastric cancer surgery while also making the procedure less challenging. To assist clinical surgeons and provide them with an option, the lymph node tracer approach that is more suited for robot surgical systems is chosen comparing two tracer methods |
Carbon Nanoparticles vs Indocyanine Green | Carbon NPs | NCT04759820 | While both carbon NPs and ICG as lymph node tracers in colorectal cancer surgeries have their value, the study aims to compare two tracers to determine the most effective. It will help to further improve postoperative lymph node inspection, precise postoperative adjuvant therapy, and patient long-term survival |
Application of Carbon Nanoparticles in Laparoscopic Colorectal Surgery | Carbon NPs | NCT03350945 | The project aims to assess the application of carbon NPs for tumour localization and lymph node mapping during laparoscopic colorectal surgery in terms of its security, efficacy, accuracy, and cost-effectiveness |
The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer | 64Cu-NOTA-PSMA-PEG-Cy5.5-C' | NCT04167969 | This study examines the safety of identifying tumour cells before and during prostate cancer surgery utilizing the 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer. The study aims to determine whether PET/MRI scans performed after the injection of this experimental tracer are more accurate than standard imaging scans for locating prostate tumour cell masses. The tracer's biodistribution will be monitored, and the use of this tracer in patients undergoing surgery for prostate cancer will be studied for the first time [88] |
Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases | cRGDY-PEG-Cy5.5 | NCT02106598 | Patients received standard-of-care technetium Tc 99Â m sulfur colloid before receiving an intradermal microdose of integrin-targeting, dye-encapsulated NPs with polyethylene glycol chains on their surfaces. These NPs are called cRGDY-PEG-Cy5.5. This study established the viability and safety of fluorescence-guided sentinel LN biopsy using cRGDY-PEG-Cy5.5 in head and neck melanoma. With the potential to reduce procedural risks, this method holds promise for enhancing lymphatic mapping and SLN biopsy operations [89] |
A 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 | Pegsitacianine (ONM-100) | NCT05048082 | A Phase 2, Single-Dose, Open-Label Study to Assess the Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for Lung Malignancies Detection of in Patients Having Routine Surgery. Micelles covalently coupled to indocyanine green constitute the NP-based fluorescent imaging agent pegsitacianine. Other Names: ONM-100 |
A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Peritoneal Metastases in Patients Undergoing Cytoreductive Surgery | Pegsitacianine (ONM-100) | NCT04950166 | Patients undergoing cytoreductive surgery are given pegsitacianine to assist surgeons in identifying peritoneal metastases. Pegsitacianine takes advantage of the constant pH variations between healthy and malignant tissues. The localization within the tumour microenvironment offers a highly-sensitive, focused fluorescence response, enabling the detection of primary tumours, their margins, metastatic disease, and lymph nodes containing tumours |
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer | Pegsitacianine (ONM-100) | NCT03735680 | The purpose of this study is to assess the diagnostic performance, safety, and timeliness of ONM-100 post-dose imaging, in patients with solid tumours undergoing standard surgery (breast cancer, head and neck squamous cell carcinoma, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma, non-small cell lung cancer) |
Cathepsin Activatable Fluorescent Probe | LUM015 | NCT01626066 | The goal of this study is to establish a safe dosage of LUM015. According to a mouse-human phase 1 co-clinical study, the tumour selectivity of protease-activated imaging probes, such as LUM015, relays on both biodistribution and enzyme activity. LUM015 is selectively delivered to tumours, where proteases then activate it [90] |
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers | LUM015 | NCT02584244 | This feasibility study's main objective is to evaluate the LUM015's initial safety and effectiveness for ex vivo far-red imaging of colorectal, pancreatic, and oesophageal malignancies (adenocarcinoma). LUM015 will be given 2–6 h before tumour excision colorectal and oesophageal cancer cases. For pancreatic patients, the injection will take place one hour before the scheduled start of the surgery |
Feasibility Study of Intraoperative Imaging in Breast Cancer | LUM015 | NCT02438358 | During breast cancer surgery, the LUM015/LUM2.6 Imaging System enables the real-time detection of residual tumours in the lumpectomy cavity and may lower the percentage of positive margins while also lowering the amount of tissue removed [91] |
Feasibility Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients | LUM015 | NCT04440982 | Enrollment and interim analysis are completed for Cohort 1. The fluorescence signals obtained, were within the predicted range, and no additional concerns, particular to this patient cohort, were found. Cohort 2 now has four more patients [92] |
Feasibility of the LUM Imaging System for Detection of Prostate Cancer | LUM015 | NCT03441464 | This feasibility study's primary goal is to assess whether administering LUM015 to patients having radical prostatectomy for prostate cancer would cause tumor tissue from ex vivo specimens to fluoresce positively. Imaging and analyses of both tumor and healthy tissue will be performed |
Feasibility of the LUM Imaging System for Detection of Cancer in the Brain | LUM015 | NCT03717142 | This study aims to evaluate the LUM Imaging System's safety and efficacy in imaging primary and metastatic cancer in the brain. This involves determining a starting dose of LUM015 for molecular imaging of low-grade gliomas, glioblastomas, and cancer masses that have metastasized to the brain |
Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies | LUM015 | NCT03834272 | This single-site feasibility research will evaluate the LUM Imaging System’s initial safety and effectiveness for in vivo imaging of metastases to the peritoneum from primary gastrointestinal cancer, ovarian cancer, and mesothelioma. It feasibility study is divided into two parts: (a) a dosage escalation phase to determine the appropriate dose, followed by (b) further patient enrolment to develop the tumor detection algorithm |
Intraoperative Detection of Residual Cancer in Breast Cancer | LUM015 | NCT03321929 | It is a multi-site, non-randomized, open-label trial to collect data on the safety and efficacy of the LUM Imaging System in finding residual cancer in breast cancer patients. LUM05's safety profile was comparable to that of other imaging agents used in breast cancer surgery, and it was related to a lower need for a second surgery in patients who received intraoperative excision of LUM05-guided shaves [93] |
Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) | LUM015 | NCT03686215 | This pivotal study is multi-centre, two-arm, randomized, and blinded. Its goal is to show the safety and effectiveness of the LUM Imaging System in identifying residual cancer in lumpectomy surgery to support surgeons in decreasing the rates of positive margins |
Feasibility Study of LUM Imaging System for Pancreatic Cancer | LUM015 | NCT04276909 | This single-site, non-randomized, open-label trial aims to evaluate the initial safety and effectiveness of the LUM Imaging System for primary pancreatic cancer and primary pancreatic cancer-related peritoneal invasion during surgery. The algorithm for tumour identification will be developed for this indication in this feasibility study |