PanTheR Registry Trial

Not yet recruiting

• Conditions: Solid Tumors

• Registration Number: NCT06805461
• Lead Sponsor: RenovoRx

Brief Summary

This study is a multicenter, observational, post-marketing, registry study designed to track the safety and performance of the RenovoCath® device and assess survival outcomes in patients diagnosed with solid tumors who are treated with localized intra-arterial (IA) delivery of therapeutic agents to solid tumors using the RenovoCath® catheter.

Detailed Description

This study will enroll patients diagnosed with solid tumors who are willing to participate in the registry and meet the study enrollment criteria. Participants will be treated with therapeutic agents using RenovoCath® for the approved intended use according to the current country-specific Instructions for Use (IFU). Participants will be followed for survival outcome. Patients may chose to consent to participation in the registry before, during, or after treatment with the RenovoCath® device.

This observational post-marketing registry study is intended to track the safety and performance of the RenovoCath® device and assess patient survival / clinical outcomes of RenovoCath® in a real-world, clinical, observational setting when used for targeted delivery of therapeutic agents. Up to 1000 patients will be enrolled at up to an estimated 100 sites. Each patient participating in the registry study will have medical record retrievals including past data as of the time of their initial diagnosis through all localized IA administrations of therapeutic agent(s) using RenovoCath®, with continued record retrieval through the end of patient follow-up to record mortality rates. Patient data collection will include prior treatment history. Patients and/or their families will be contacted periodically after the treatment(s) to assess survival. It is anticipated that each participating patient's records will be retrieved approximately four times throughout the course of their treatment and follow-up, or retrospectively should patents decide to participate in the registry upon the completion of their treatment or during follow-up. This registry study is expected to continue for six years from study commencement.

Study Timeline

• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-02-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Study Start: 2025-04-28
• Primary Completion: 2029-09-03
• Study Completion: 2029-09-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of RenovoCath® as assessed by the number of participants experiencing adverse events related to the chemotherapy agents administered using RenovoCath.	From the time of the first treatment, until 30 days after the last treatment	Number of participants experiencing adverse events related to the chemotherapy agents administered using RenovoCath.
Performance of RenovoCath® as assessed by the number of participants experiencing adverse events related to the inter-arterial drug delivery procedure.	From the time of the first treatment, until 30 days after the last treatment	Track the performance of RenovoCath® in a real-world setting delivering a variety of therapeutic agents

Secondary Outcome Measures

Name	Time	Method
Overall Survival	24 months from date of first treatment with IA	Evaluate overall survival (OS) in patients diagnosed with solid tumors who undergo localized IA delivery of therapeutic agents via the RenovoCath®
Tumor Response Rate	24 months from date of first treatment with IA	Assess tumor response, via imaging, in the primary site of application
Number of participants who are downstaged and have their tumor resected after IA treatment with RenovoCth	6 months from the date of the first IA treatment	The number of participants who received IA treatment with RenovoCath and later receive resection of their tumor

Trial Locations

Locations (1)

University of Pennsylvania Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States