RECRUITING

Drug Screening Using Novel IMD in Renal Cell Carcinoma

Conditions

Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Kidney Cancer Suspected Renal Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research is being done to study the safety and feasibility of implanting and retrieving a microdevice that releases microdoses of 19 specific drugs or drug combinations as a possible tool to evaluate the effectiveness of several cancer drugs against metastatic renal cell carcinoma (RCC). The name of the intervention(s) involved in this study are: * Implantable Microdevice (IMD) * Surgery (excision of tumor) * Drugs used in this study will only include drugs already used as standard of care for the treatment of metastatic renal cell carcinoma (RCC)

Official Title

Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Renal Cell Carcinoma

Quick Facts

Study Start:2023-04-24

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05700461

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must have the ability to understand and the willingness to sign a written informed consent document. * Participants must have confirmed or suspected metastatic renal cell carcinoma, and must be planned for either nephrectomy or metastatectomy as part of their clinical care. 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 the clinically appropriate treatment strategy based on clinical history and extent of disease. * Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures. * Participants will undergo laboratory testing within 30 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood 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 and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care. * The participant's case must be reviewed by representatives of interventional radiology and the appropriate surgical subspecialty to assess the following factors: * Patient is clinically stable to undergo microdevice implantation and surgical procedures * Patient has sufficient volume of disease to allow implantation of the microdevice * Patient has a lesion for which the microdevice is a) amenable to percutaneous placement, and b) amenable to removal at the time of surgery * 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.	* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery. * Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures (detailed below).

Inclusion Criteria

Exclusion Criteria

* Patients must have the ability to understand and the willingness to sign a written informed consent document.
* Participants must have confirmed or suspected metastatic renal cell carcinoma, and must be planned for either nephrectomy or metastatectomy as part of their clinical care. 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 the clinically appropriate treatment strategy based on clinical history and extent of disease.
* Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures.
* Participants will undergo laboratory testing within 30 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood 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 and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care.
* The participant's case must be reviewed by representatives of interventional radiology and the appropriate surgical subspecialty to assess the following factors:
* Patient is clinically stable to undergo microdevice implantation and surgical procedures
* Patient has sufficient volume of disease to allow implantation of the microdevice
* Patient has a lesion for which the microdevice is a) amenable to percutaneous placement, and b) amenable to removal at the time of surgery
* 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.

* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures (detailed below).

Contacts and Locations

Study Contact

Wenxin Xu, MD

CONTACT

617-632-6534

Wenxin_Xu1@dfci.harvard.edu

Principal Investigator

Wenxin Xu, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Wenxin Xu

Wenxin Xu, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-24

Study Completion Date2026-03

Study Record Updates

Study Start Date2023-04-24

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Kidney Cancer
Suspected Renal Cell Carcinoma

Additional Relevant MeSH Terms

Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Kidney Cancer