Clinical trial · Interventional
Microdevice for Evaluating Drug Response in Site in Lung Lesions
Pilot Study of Microdevice for Evaluating Drug Response in Site in Lung Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Tumor | Lung Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microdevice loaded with 19 chemotherapeutic agents | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Microdevice Intervention
- description
- 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.
- interventionNames
- Combination Product: Microdevice loaded with 19 chemotherapeutic agents
Primary outcomes (2)
- measure
- Incidence of treatment-emergent adverse events (safety and feasibility) related to the placement and removal of the microdevice.
- timeFrame
- 5 years
- description
- Safety will be measured quantitatively by the number of participants with treatment-related adverse events.
- measure
- Number of histopathology analyses and interpretations for drugs eluted from microdevice reservoirs into resected lung lesion tissue.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTsai 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