On October 20, 2021 Lightpoint Medical, a leading medical device company developing and marketing innovative technologies for intra-operative cancer detection, reported that clinical trial results today to support the use of the company’s miniature surgical gamma probe, SENSEI, in prostate sentinel lymph node detection (Press release, lightpoint medical, OCT 20, 2021, View Source [SID1234591619]).
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The interim results from the multi-center clinical trial, which involves cancer centers at Hospital del Mar, Barcelona, Spain; Institut Paoli-Calmettes, Marseille, France; and UZ Leuven, Belgium; demonstrate a 100% detection rate of sentinel lymph nodes using SENSEI in minimally-invasive and robot-assisted prostate cancer surgery.
The results also indicate that SENSEI performed better than standard rigid gamma probes, as SENSEI found additional pelvic sentinel nodes in anatomically restricted areas which could not be detected by the rigid gamma probe. The final study results, expected in Q1 2022, will provide further insights into the performance differences between SENSEI and rigid gamma probes.
The trial results will be presented today at the Annual Congress of the European Association of Nuclear Medicine.
The clinical trial results demonstrate the ease of use and performance of SENSEI in prostate cancer surgery and signal potential application in other surgical procedures across major cancer types.
Principal Investigator, Dr. Lluís Fumadó, Hospital del Mar, Barcelona said "These clinical trial results demonstrate that the use of SENSEI in prostate cancer surgery dramatically enhances our surgical management of prostate cancer patients and is shown to effectively detect sentinel lymph nodes. We look forward to using SENSEI in more procedures and evaluating the probe in combination with the new targeted imaging agent, 99mTc-PSMA, for direct detection of disease metastasis in pelvic lymph nodes."
Lightpoint Medical CEO, Graeme Smith, added "There are active clinical studies at multiple cancer centers evaluating SENSEI in prostate, cervical, and colorectal cancer with studies in lung and endometrial cancer in the pipeline. These positive and highly encouraging results from our multi-center study evaluating SENSEI in prostate cancer surgery demonstrate the ease of use and performance of SENSEI and signal potential application in other major cancer types to detect cancer intra-operatively. All of us at Lightpoint Medical are incredibly grateful to Dr. Lluís Fumadó and the team at Hospital del Mar for leading this study and to all the clinical centers and patients who are working with us."
About SENSEI
Lightpoint Medical has developed SENSEI – a miniaturized surgical gamma probe for minimally-invasive and robot-assisted cancer surgery. The device is approved for sale in the US, EU, UK, and Australia. SENSEI can detect gamma emissions from radiopharmaceuticals. The first application of the device is sentinel lymph node detection in prostate and cervical cancer surgery. It is anticipated that SENSEI will also have application in the direct detection of lymph node metastasis using breakthrough imaging agents such as 99mTc-PSMA in prostate cancer surgery and in radio-guided occult lesion detection in lung cancer surgery.
About sentinel lymph node detection
The intra-operative detection of sentinel lymph nodes is necessary when performing a sentinel lymph node biopsy (SLNB) procedure. The sentinel node is the first lymph node draining from the primary tumor. By identifying and removing the sentinel node during surgery, it is possible to determine whether cancer has spread through the lymphatic system. SLNB is commonly used in multiple cancer types. However, performing SLNB in minimally-invasive and robot-assisted surgery is challenging due to usability limitations when using conventional long rigid gamma probes. SENSEI is a small, flexible gamma probe designed for minimally-invasive and robotic surgery and has the potential to improve SLNB in intra-cavity procedures such as those of the pelvis.