Clinical trial NCT03972228: Microdevice for Evaluating Drug Response in Site in Lung Lesions
Official title: Pilot Study of Microdevice for Evaluating Drug Response in Site in Lung Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Lung Tumor
Lung Cancer
Keywords: microdevice
chemotherapy
lung lesions
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2019-06-03
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients with a suspicious lung lesion for which surgery is indicated for either diagnostic or therapeutic purposes, as determined by the treating thoracic surgeon
* Masses with a minimum longest dimension of 1 cm
* 18 years of age or older
* Documented, signed, dated informed consent for both the surgical resection as well as the proposed research study obtained prior to any procedures

Exclusion Criteria:

* Subjects who do not wish to undergo surgical resection, or those who are high-risk or not candidates for surgical resection in the opinion of the treating surgeon
* Women of childbearing potential without a negative pregnancy test; or women who are lactating

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (safety and feasibility) related to the placement and removal of the microdevice.
timeFrame: 5 years
measure: Number of histopathology analyses and interpretations for drugs eluted from microdevice reservoirs into resected lung lesion tissue.
timeFrame: 5 years
Secondary outcomes:
measure: Stratification of local tumoral cellular responses to various agents and combinations of agents released from the microdevice reservoirs.
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Yolonda L Colson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: