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IMD Drug Screening for Kidney Cancer

Phase 1

Recruiting

Led By Wenxin Xu, MD

Research Sponsored by Wenxin Xu

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories

Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

Study Summary

This trial studies a microdevice that releases small doses of cancer drugs to test their effectiveness against RCC. Surgery and existing cancer drugs are also involved.

Who is the study for?

This trial is for adults with metastatic renal cell carcinoma who are stable enough for surgery and have a tumor at least 1cm in size. They must be evaluated by an oncologist, have certain blood count levels, and agree to genetic testing. People with uncontrolled illnesses or bleeding disorders that increase surgical risks can't participate.Check my eligibility

What is being tested?

The study tests the safety of implanting and retrieving a microdevice (IMD) that releases tiny amounts of cancer drugs into kidney tumors. The IMD contains 19 drugs used in standard care, aiming to find the most effective treatment strategy for each patient.See study design

What are the potential side effects?

While specific side effects aren't listed, potential risks may include those associated with surgical procedures such as infection, bleeding, or reaction to anesthesia; and any known side effects of the standard RCC medications contained within the IMD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to have my genetic information used for research and stored anonymously.

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I am medically fit for surgery and other procedures.

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I have kidney cancer that has spread, and surgery to remove it is planned.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients with Feasible Microdevice Procedure

Number of Patients with Safe Microdevice Procedure

Trial Design

1Treatment groups

Experimental Treatment

Group I: Implantable microdevice (IMD) + Biopsy + Standard of Care TreatmentExperimental Treatment1 Intervention

Participants with confirmed or suspected metastatic Renal Cell Carcinoma (RCC) and who are candidates for standard of care metastatectomy or debulking/consolidative nephrectomy will be selected for study participation and will undergo study procedures as outlined: Placement of 1-6 microdevice(s) 72 +/- 24 hours prior to scheduled, standard of care surgery. The number of microdevices implanted into a tumor will be made on a case-by-case basis based on tumor and participant factors before and during the procedure. At the time of standard of care surgery, surgical removal of microdevice(s) along with surrounding tumor tissue. Monitoring for safety endpoints during inpatient stay and at a follow-up clinic visit.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wenxin XuLead Sponsor

Wenxin Xu, MDPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

5 Total Patients Enrolled

Media Library

Implantable Microdevice (IMD) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05700461 — Phase 1

Kidney Cancer Research Study Groups: Implantable microdevice (IMD) + Biopsy + Standard of Care Treatment

Kidney Cancer Clinical Trial 2023: Implantable Microdevice (IMD) Highlights & Side Effects. Trial Name: NCT05700461 — Phase 1

Implantable Microdevice (IMD) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05700461 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of Implantable microdevice (IMD), Biopsy and Standard of Care Treatment been approved by the FDA?

"The safety rating for the combination of Implantable microdevice (IMD) + Biopsy + Standard of Care Treatment was assigned a 1 based on its Phase 1 designation, indicating limited evidence supporting both efficacy and safety."

Answered by AI

Are clinicians currently enrolling participants for this experimental research?

"According to clinicaltrials.gov, this medical trial is no longer recruiting and was last updated on the 17th of January 2023. However, a plethora of other studies are currently in need of patients with 2582 trials being actively open for enrollment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Drug Screening Using Novel IMD in Renal Cell Carcinoma

Wenxin Xu 2023. "Drug Screening Using Novel IMD in Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05700461.

All > Renal Cell Carcinoma