Microdevice for Evaluating Drug Response in Site in Lung Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03972228|
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Tumor Lung Cancer||Combination Product: Microdevice loaded with 19 chemotherapeutic agents||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Microdevice for Evaluating Drug Response in Site in Lung Lesions|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||October 1, 2021|
Experimental: Microdevice Intervention
The intervention to be administered is the placement of the microdevice containing 19 FDA-approved drugs into the lung lesion and the device's subsequent surgical resection. All study subjects will receive this same intervention; there is only one arm.
Combination Product: Microdevice loaded with 19 chemotherapeutic agents
The microdevice containing 19 FDA-approved chemotherapeutic agents will be placed in the suspected tumor tissue at the time of surgical resection. Multiple chemotherapeutic 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.
- Incidence of treatment-emergent adverse events (safety and feasibility) related to the placement and removal of the microdevice. [ Time Frame: 5 years ]Safety will be measured quantitatively by the number of participants with treatment-related adverse events.
- Number of histopathology analyses and interpretations for drugs eluted from microdevice reservoirs into resected lung lesion tissue. [ Time Frame: 5 years ]Feasibility will be based on the ability to retrieve the device with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of the device reservoirs.
- Stratification of local tumoral cellular responses to various agents and combinations of agents released from the microdevice reservoirs. [ Time Frame: 5 years ]This initial proof-of-concept pilot study will gauge the ability of using the microdevice to predict tumor drug response, allowing a stratified systemic treatment to prioritize those agents inducing the greatest anti-tumor response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972228
|Contact: Yolonda L Colson, MD, PhD||617-726-5200||YCOLSON@PARTNERS.ORG|
|Contact: William Phillips, MDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Yolonda L Colson, MD, PhD 617-726-5200 firstname.lastname@example.org|
|Contact: Diane Davies, RN 617-643-4390 DDAVIES@PARTNERS.ORG|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Matthew Rochefort, MD 617-732-7157 MROCHEFORT@PARTNERS.ORG|
|Principal Investigator:||Yolonda L Colson, MD, PhD||Massachusetts General Hospital|