CompletedEarly Phase 1NCT03972228
Official study title

Microdevice for Evaluating Drug Response in Site in Lung Lesions

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedMicrodevice loaded with 19 chemotherapeutic agents

The study team can explain what participation involves.

Who it may be forLung Tumor · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 17, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Early Phase 1

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Oliver Jonas

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Early Phase 1
Sponsor
Oliver Jonas
Interventions being studied
Combination Product: Microdevice loaded with 19 chemotherapeutic agents
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Massachusetts General HospitalBoston, Massachusetts
  • Brigham and Women's HospitalBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 17, 2021. Always confirm current availability with the study team.

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