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NCT07892300

Implantable Microdevices for in Situ Evaluation of Drug Responses in Lung Cancer

StatusNot Yet Recruiting
PhaseEarly Phase 1
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Safety of microdevice implantation and indwelling
Timeframe: up to 30 days

Secondary (1)

Feasibility of assessing tissue responses from microdevice treated tumor regions

Arms and interventions

Implantable Microdevice (IMD) + Standard-of-care Surgical Retrieval + Standard-of-Care TreatmentExperimental

Participants with confirmed or suspected lung cancer or malignant mesothelioma who are candidates for standard-of-care surgical tumor resection will be eligible for study participation and will undergo the following study procedures: * \*\*Microdevice implantation:\*\* Placement of 1-4 investigational drug-releasing microdevices into an accessible tumor approximately 72 ± 24 hours prior to scheduled standard-of-care surgery. Microdevices may be implanted using image-guided percutaneous techniques or other clinically appropriate approaches, depending on tumor location and accessibility. The number of microdevices implanted will be determined on a case-by-case basis based on tumor characteristics, anatomical location, procedural feasibility, and participant-specific considerations. * \*\*Microdevice retrieval and tissue collection:\*\* At the time of scheduled standard-of-care surgery, the implanted microdevices will be surgically retrieved along with surrounding tumor tissue and analyzed.

Drugs: Implantable Micro- drug delivery Microdevice (IMD)