Last updated: June 20, 2023
Sponsor: Wenxin Xu
Overall Status: Active - Recruiting
Phase
1
Condition
Carcinoma
Cancer/tumors
Kidney Cancer
Treatment
Implantable Microdevice (IMD)
Clinical Study ID
NCT05700461
22-492
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients must have the ability to understand and the willingness to sign a writteninformed consent document.
- Participants must have confirmed or suspected metastatic renal cell carcinoma, andmust be planned for either nephrectomy or metastatectomy as part of their clinicalcare. The lesion planned for excision must be at least 1cm in size.
- Participants must be 18 years of age or older.
- Participants must be evaluated by a medical oncologist who will determine theclinically appropriate treatment strategy based on clinical history and extent ofdisease.
- Patients must be deemed medically stable to undergo both percutaneous procedures andstandard-of-care surgical procedures.
- Participants will undergo laboratory testing within 30 days prior to the procedure (orwithin 72 hours if there has been a change in the clinical status since the initialblood draw). Patients must have absolute neutrophil count ≥1,000/mcL, platelets ≥50,000/mcL, PT (INR) 1.5 and PTT <1.5x control.
- Participants must have undergone CT or MRI that assesses the extent of disease andallows the research team to assess for study eligibility. This will have been done aspart of the standard-of-care.
- The participant's case must be reviewed by representatives of interventional radiologyand the appropriate surgical subspecialty to assess the following factors:
- Patient is clinically stable to undergo microdevice implantation and surgicalprocedures
- Patient has sufficient volume of disease to allow implantation of the microdevice
- Patient has a lesion for which the microdevice is a) amenable to percutaneousplacement, and b) amenable to removal at the time of surgery
- Patients must be willing to undergo research-related genetic sequencing (somatic andgermline) and data management, including the deposition of de-identified geneticsequencing data in NIH central data repositories.
Exclusion
Exclusion Criteria:
- Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, unstablecardiac arrhythmia, or psychiatric illness/social situations that would limit thesafety of a biopsy and/or surgery.
- Uncorrectable bleeding or coagulation disorder known to cause increased risk withsurgical or biopsy procedures (detailed below).
Study Design
Total Participants: 5
Treatment Group(s): 1
Primary Treatment: Implantable Microdevice (IMD)
Phase: 1
Study Start date:
April 24, 2023
Estimated Completion Date:
March 31, 2026
Study Description
Connect with a study center
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
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