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Microdevice for Evaluating Drug Response in Site in Lung Lesions

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ClinicalTrials.gov Identifier: NCT03972228
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Oliver Jonas, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Lung Tumor Lung Cancer Combination Product: Microdevice loaded with 19 chemotherapeutic agents Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Yolonda L Colson, MD, PhD 617-726-5200 YCOLSON@PARTNERS.ORG
Contact: William Phillips, MD wwphillips@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Yolonda L Colson, MD, PhD    617-726-5200    ycolson@partners.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   
Sponsors and Collaborators
Oliver Jonas
Massachusetts General Hospital
Investigators
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Principal Investigator: Yolonda L Colson, MD, PhD Massachusetts General Hospital

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Responsible Party: Oliver Jonas, Co-Investigator, Division of Radiology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03972228     History of Changes
Other Study ID Numbers: 2017P002401
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Oliver Jonas, Brigham and Women's Hospital:
microdevice
chemotherapy
lung lesions
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents