Microdevice for Evaluating Drug Response in Site in Lung Lesions

NCT03972228 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 2017P002401
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Tumor; Lung Cancer

Keywords

microdevice; chemotherapy; lung lesions

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events (safety and feasibility) related to the placement and removal of the microdevice.

  Safety will be measured quantitatively by the number of participants with treatment-related adverse events.

  5 years

• Number of histopathology analyses and interpretations for drugs eluted from microdevice reservoirs into resected lung lesion tissue.

  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.

  5 years

Secondary Outcomes (1)

• Stratification of local tumoral cellular responses to various agents and combinations of agents released from the microdevice reservoirs.

  5 years

Study Arms (1)

Microdevice Intervention

EXPERIMENTAL

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

Interventions

Microdevice loaded with 19 chemotherapeutic agents COMBINATION_PRODUCT

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.

Microdevice Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oliver Jonas: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Tsai LL, Phillips WW, Hung YP, Dominas C, Deans K, Ahn S, Ferland B, Weiss K, Lanuti M, Auchincloss H, Schumacher L, Jonas O, Colson YL. First-in-Human Intrathoracic Implantation of Multidrug-Eluting Microdevices for In Situ Chemotherapeutic Sensitivity Testing as Proof of Concept in Nonsmall Cell Lung Cancer. Ann Surg. 2023 May 1;277(5):e1143-e1149. doi: 10.1097/SLA.0000000000005385. Epub 2023 Apr 6.

  PMID: 35129472 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yolonda L Colson, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator, Division of Radiology

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: June 3, 2019
• Study Start: October 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

US (2)