Microdevice for Evaluating Drug Response in Site in Lung Lesions

Status Completed

Clinical Trial Summary

This is a pilot study for placement of a tiny microdevice into lung tumors to more precisely predict tumor-specific drug sensitivity, and to help inform systemic therapeutic decisions. The microdevice will provide a novel technique for interrogating human lung tumor tissue in situ, and will uniquely facilitate assessment of response to multiple drugs simultaneously. This will not only increase the specificity of a particular participant's chosen systemic therapy, it will also augment the speed and efficiency with which investigators are able to make clinical decisions regarding choice of therapy.

Clinical Trial Description

The initial aims in this pilot study will focus on the safety and feasibility of microdevice placement and retrieval in participants with suspicious lung lesions. The microdevice, which is 5.5 mm in length and approximately 750 µm in diameter (i.e., comparable in size and shape to commonly used fiducial markers), will be placed in the suspected tumor tissue at the time of surgical resection. Multiple agents will passively diffuse into local, confined regions (several microns) of the surrounding microenvironment. The agents are released at approximately one millionth of a systemic dose. The device(s) will be removed for analysis at the time of resection, which will be performed for clinical indications independent of enrollment in this study. The investigators will collect data regarding the safety and feasibility of the placement and retrieval of the microdevices, and perform detailed tissue analysis of drug response. Investigators hope to compile preliminary data regarding correlations between in situ drug response and the genetic and histopathologic features of tumors, systemic treatment response, and ultimately, clinical outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03972228
Study type	Interventional
Source	Brigham and Women's Hospital
Contact
Status	Completed
Phase	Early Phase 1
Start date	October 1, 2018
Completion date	September 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03918538` - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors	N/A
Recruiting	`NCT05078918` - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors	N/A
Active, not recruiting	`NCT04548830` - Safety of Lung Cryobiopsy in People With Cancer	Phase 2
Completed	`NCT04633850` - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A
Recruiting	`NCT05583916` - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery	N/A
Active, not recruiting	`NCT00341939` - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting	`NCT06376253` - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers	Phase 1
Recruiting	`NCT05898594` - Lung Cancer Screening in High-risk Black Women	N/A
Recruiting	`NCT05060432` - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT03575793` - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer	Phase 1/Phase 2
Active, not recruiting	`NCT03667716` - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.	Phase 1
Terminated	`NCT01624090` - Mithramycin for Lung, Esophagus, and Other Chest Cancers	Phase 2
Terminated	`NCT03275688` - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting	`NCT04931420` - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels	Phase 2
Recruiting	`NCT06052449` - Assessing Social Determinants of Health to Increase Cancer Screening	N/A
Recruiting	`NCT06010862` - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors	Phase 1
Not yet recruiting	`NCT06017271` - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting	`NCT05787522` - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk