Intraoperative Dual-modality Imaging in Renal Cell Carcinoma

NCT02497599 | Unknown Phase 1 DMC

• 1 other identifier: 13071988
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative tumor localization and resection can be enhanced using intraoperative fluorescence imaging and radiodetection. Girentuximab specifically recognizes carbonic anhydrase IX expressed on \> 95% of renal cell carcinoma (RCC). Therefore Indium-111-DOTA-girentuximab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in RCC. The aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with Indium-111-DOTA-girentuximab-IRDye800CW in renal cell carcinoma patients.

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (1)

• Fluorescent signal at time of surgery

  Can the tumor be identified by the fluorescent signal? Yes/No. Can the tumor be distinguished from normal tissue? Yes/No

  During surgery

Secondary Outcomes (3)

• Safety of dual-labeled antibody injection as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0

  4 weeks

• Blood levels of the dual-labeled antibody

  60, 120 and 180 minutes after injection and 4 and 7 days after injection

• Optimal dose of the dual-labeled antibody preparation

  4 weeks

Study Arms (1)

Intraoperative dual-modality imaging

EXPERIMENTAL

Patients receive a single intravenous dose of Indium-111-DOTA-Girentuximab-IRDye800CW. At day 4 or 5 after antibody injection a whole body planar scan and SPECT/CT scan will be acquired. At day 7 standard of care (partial) nephrectomy will be performed. This will be extended with the use of dual-modality imaging.

Drug: Indium-111-DOTA-Girentuximab-IRDye800CW; Radiation: SPECT/CT; Procedure: Intraoperative dual-modality imaging

Interventions

Indium-111-DOTA-Girentuximab-IRDye800CW DRUG

Indium-111-DOTA-Girentuximab-IRDye800CW tracer injection will be administered 7 days before (partial) nephrectomy

Also known as: Dual-labeled girentuximab

Intraoperative dual-modality imaging

SPECT/CT RADIATION

4 or 5 days after tracer injection a SPECT/CT of the abdomen will be acquired.

Intraoperative dual-modality imaging

Intraoperative dual-modality imaging PROCEDURE

7 days after dual-labeled girentuximab injection standard of care surgery will be performed extended with the use of dual-modality imaging.

Also known as: Fluorescence and radioguided surgery

Intraoperative dual-modality imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of clear cell renal cell carcinoma planned for surgery, (partial) nephrectomy
• Performance status: Karnofsky 70 %
• Being fit for surgery
• Minimum age 18 years
• Signed informed consent

You may not qualify if:

• A known subtype other than clear cell RCC
• Any medical condition present that in the opinion of the investigator will affect patients' clinical status.
• Administration of a radioisotope within 10 physical half lives prior to study enrollment
• Pregnancy and lactation

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Fluorescence

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Luminescence; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena

Study Officials

• Peter FA Mulders, M.D. PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Wim JG Oyen, M.D. PhD

  Radboud University Medical Center

  STUDY DIRECTOR

Central Study Contacts

Robin Merkx, Drs.

CONTACT

0031243666283; Robin.Merkx@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: July 14, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)