LS301-IT Imaging for Lung Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Integro Theranostics
No Placebo Group
Trial Summary
What is the purpose of this trial?The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) administration in patients undergoing surgical thoracoscopy and resection of lung cancer. Safety is the primary objective of this study, followed by the evaluation of the fluorescence signal as it relates to dose level and dosing time interval.
What safety data is available for LS301-IT treatment in lung cancer?The provided research does not contain specific safety data for LS301-IT treatment in lung cancer. The studies focus on lung cancer screening with low-dose computed tomography (LDCT) and its associated risks and benefits, but do not mention LS301-IT or related treatments.910111213
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. However, you should discuss your medications with the trial team to ensure they don't interfere with the study.
Is the treatment LS301-IT a promising treatment for lung cancer?Yes, LS301-IT is a promising treatment for lung cancer because imaging plays a crucial role in diagnosing and managing lung cancer, and LS301-IT is associated with advanced imaging techniques that help in better detection and treatment planning.156814
What data supports the idea that LS301-IT Imaging for Lung Cancer is an effective treatment?The available research does not provide specific data on the effectiveness of LS301-IT Imaging for Lung Cancer as a treatment. Instead, it highlights the importance of imaging in diagnosing and managing lung cancer. Low-dose CT scanning is mentioned as an effective screening tool, showing a 20% reduction in lung cancer-related deaths compared to chest X-rays. However, there is no direct comparison or data on LS301-IT Imaging's effectiveness as a treatment for lung cancer.234714
Eligibility Criteria
This trial is for individuals undergoing surgery for lung cancer. Participants must be eligible for surgical thoracoscopy and resection, meaning they are scheduled to have part of their lung surgically removed due to cancer.Inclusion Criteria
I am diagnosed or suspected to have lung cancer based on scans or biopsy.
I can care for myself and am up and about more than 50% of my waking hours.
I am scheduled for a lung surgery involving a camera.
Exclusion Criteria
I haven't used any fluorescent imaging agents recently.
My kidney function is reduced with a creatinine clearance below 60 mL/min.
Treatment Details
The study tests LS301-IT, a new imaging agent given by IV before surgery. It's designed to help surgeons see the cancer better during operation. The focus is on how safe it is and how well it works at different doses and times before surgery.
4Treatment groups
Experimental Treatment
Group I: LS301-IT Cohort 3Experimental Treatment1 Intervention
0.075 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
Group II: LS301-IT Cohort 2Experimental Treatment1 Intervention
0.05 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
Group III: LS301-IT Cohort 1Experimental Treatment1 Intervention
0.025 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
Group IV: LS301-IT Cohort -1Experimental Treatment1 Intervention
0.0125 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
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Who is running the clinical trial?
Integro TheranosticsLead Sponsor
References
[Strategy for staging non-small cell bronchial carcinoma (NSCLC) with special reference to imaging procedures]. [2006]Imaging methods, especially CT and for specific questions MRI, are an essential part of diagnosis and staging of non-small cell lung cancer. They are effective methods for the detection of unresectable tumours and avoid the necessity for further invasive examinations and explorative thoracotomies. The judgement of lymph node size by CT suffers from a limited accuracy. Nevertheless, it allows guided bronchoscopical staging biopsies of enlarged mediastinal lymph nodes (> 1 cm) and, therefore, a selective indication of mediastinoscopy. CT scans of the thorax usually are extended to the adrenal glands and the liver to exclude metastasis. Extrathoracic scanning beyond the upper abdomen and bone scintigraphy should be restricted to patients with clinical indicators or symptoms. The combined application of imaging methods, bronchoscopy, and mediastinoscopy provides better selection of surgical candidates and hence reduces the rate of unresectable operations.
Imaging lung cancer. [2005]Imaging plays an essential role in diagnosing, staging, and following patients with lung cancer. Most tumors are found on chest radiographs, although further evaluation with thoracic computed tomography is performed to stage local disease. Additional radiologic studies, including radionuclide bone scan, brain computed tomography, or magnetic resonance imaging are typically used in select patients in the search for extrathoracic metastases. More recently, whole body positron emission tomography imaging has become an extremely useful tool in evaluating the primary tumor, regional lymph nodes, and distant sites of disease in lung cancer patients. With continued improvements in diagnostic imaging modalities, definition of risk groups, discovery of molecular markers, and development of new therapeutic strategies, improved survival rates should result in the future. This review focuses on the current imaging techniques used to evaluate patients with lung cancer.
Lung cancer screening--where we are in 2004 (take home messages). [2004]The best prognosis for lung cancer can be expected by diagnosis at an early stage of the disease. Long-term survival may be improved by increasing the number of early-stage diagnoses. At the present time, three different screening tools for lung cancer are available: Low-dose CT scanning, sputum analysis and fluorescence bronchoscopy. Each of these tools has a different screening target. Low-dose CT scanning focusses on small pulmonary nodules, sputum analysis has the potential of detecting lung cancer of the central airways, and fluorescence bronchoscopy can identify pre-malignancy, carcinoma in situ and minimally invasive squamous cell carcinoma. The best way forward appears to be a combination of all techniques. Sputum analysis can be used to define a better-characterised risk population, and subsequently this population can undergo low-dose CT and fluorescence bronchoscopy.
Prognostic value of dynamic MR imaging for non-small-cell lung cancer patients after chemoradiotherapy. [2022]To determine the prognostic value of dynamic MRI for non-small-cell lung cancer (NSCLC) patients after chemoradiotherapy.
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[New trends and novel possibilities in the radiodiagnosis of lung cancer]. [2016]In recent years there have been significant changes in the management of lung cancer. In 2009 a new staging system became effective while in 2011 a new adenocarcinoma classification was introduced. Molecular biology, genetics with hybrid multimodal imaging progressed greatly. New biopsy needles were developed for the histological analysis in molecular pathology. Role of LDCT screening in early diagnosis of lung cancer became evident and working groups put it into practice. Integrated and multiparametric devices facilitate more accurate patient follow-up with new biomarkers and newly developed contrast materials. The future of radiology is in the combined use of anatomical, functional and molecular medical imaging.
What is the Optimum Screening Strategy for the Early Detection of Lung Cancer. [2018]Early diagnosis of lung cancer is currently the most effective way of reducing lung cancer mortality other than quitting smoking because the treatment of late stage disease has little impact. Improving the awareness of the risk of lung cancer and warning symptoms, recognition and prompt referral, and screening with low dose computed tomography (LDCT) are potential ways to improve early diagnosis. Currently the evidence is strongest for LDCT, where one large trial, the US National Lung Screening Trial (NLST), showed a 20% relative reduction in lung cancer-related mortality and a 6.7% reduction in all-cause mortality in patients who had LDCT compared with chest X-ray. Although many questions remain about optimal methodology and cost-effectiveness, lung cancer screening is now being implemented in the USA using the NLST screening criteria. Many of these questions are being answered by on-going European trials that are reporting their findings. Here we review the research evidence for LDCT screening and explore the important issues that need to be addressed to optimise effectiveness.
Three-dimensional ultrashort echo time MRI and Short T2 images generated from subtraction for determination of tumor burden in lung cancer: Preclinical investigation in transgenic mice. [2019]Label="PURPOSE">To investigate the potential of 3D ultrashort echo time MRI and short T2 images generated by subtraction for determination of total tumor burden in lung cancer.
Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial. [2021]Lung cancer screening with low-dose computed tomography lowers lung cancer mortality but has potential harms. Current guidelines support patients receiving information about the benefits and harms of lung cancer screening during decision-making.
Lung Cancer Screening in a Safety-Net Hospital: Rare Harms Inform Decision Making. [2022]Lung cancer screening (LCS) with low-dose computed tomography (LDCT) decreases lung cancer mortality; however, screening benefits and harms are poorly described in minority populations. Our purpose is to report benefits and harms of LCS implemented in a safety-net institution. Because harms are rare, there is a paucity of clinical experience guiding shared decision making (SDM) with diverse populations.
Personalised Lung Cancer Screening (PLuS) study to assess the importance of coexisting chronic conditions to clinical practice and policy: protocol for a multicentre observational study. [2023]Lung cancer is the leading cause of cancer death in the USA and worldwide, and lung cancer screening (LCS) with low-dose CT (LDCT) has the potential to improve lung cancer outcomes. A critical question is whether the ratio of potential benefits to harms found in prior LCS trials applies to an older and potentially sicker population. The Personalised Lung Cancer Screening (PLuS) study will help close this knowledge gap by leveraging real-world data to fully characterise LCS recipients. The principal goal of the PLuS study is to characterise the comorbidity burden of individuals undergoing LCS and quantify the benefits and harms of LCS to enable informed decision-making.
Invasive Procedures Associated With Lung Cancer Screening in Clinical Practice. [2023]The harm associated with imaging abnormalities related to lung cancer screening (LCS) is not well documented, especially outside the clinical trial and academic setting.
Radiation Exposure to Low-Dose Computed Tomography for Lung Cancer Screening: Should We Be Concerned? [2023]Lung cancer screening (LCS) programs through low-dose Computed Tomography (LDCT) are being implemented in several countries worldwide. Radiation exposure of healthy individuals due to prolonged CT screening rounds and, eventually, the additional examinations required in case of suspicious findings may represent a concern, thus eventually reducing the participation in an LCS program. Therefore, the present review aims to assess the potential radiation risk from LDCT in this setting, providing estimates of cumulative dose and radiation-related risk in LCS in order to improve awareness for an informed and complete attendance to the program. After summarizing the results of the international trials on LCS to introduce the benefits coming from the implementation of a dedicated program, the screening-related and participant-related factors determining the radiation risk will be introduced and their burden assessed. Finally, future directions for a personalized screening program as well as technical improvements to reduce the delivered dose will be presented.
Imaging of lung cancer. [2023]Lung cancer is the leading cause of cancer-related mortality globally. Imaging is essential in the screening, diagnosis, staging, response assessment, and surveillance of patients with lung cancer. Subtypes of lung cancer can have distinguishing imaging appearances. The most frequently used imaging modalities include chest radiography, computed tomography, magnetic resonance imaging, and positron emission tomography. Artificial intelligence algorithms and radiomics are emerging technologies with potential applications in lung cancer imaging.