Zirconium-89-girentuximab PET/CT Imaging in Renal Cell Carcinoma

NCT02883153 | Completed Phase 2

• 1 other identifier: 08121986
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Girentuximab is an antibody against Carbonic Anhydrase IX (CAIX), an antigen that is expressed on the cell surface of 95% of clear cell RCC (ccRCC). Zr-89-girentuximab PET/CT (Positron Emission Tomography) may be a valuable imaging technique in the diagnosis of patients with RCC. The aim of the present study is to show the impact of the Zr-89-girentuximab PET/CT on the clinical management of ccRCC patients.

Conditions

Renal Cell Carcinoma

Keywords

Zirconium-89; PET/CT; imaging; girentuximab

Outcome Measures

Primary Outcomes (1)

• Impact on clinical decision making

  Impact on clinical decision making, defined as present or absent: * Absent: e.g. no change in treatment or follow-up * Present: e.g. change in follow-up schedule, change in surgical technique, change from surgery to active surveillance, or change from surgery to systemic treatment.

  1 year

Study Arms (1)

Zirconium-89 girentuximab PET/CT

EXPERIMENTAL

A Zirconium-89-girentuximab PET/CT will be performed 4-5 days after single intravenous injection of 5 mg Zirconium-89-girentuximab (37 MBq).

Drug: Zirconium-89 girentuximab PET/CT

Interventions

Zirconium-89 girentuximab PET/CT DRUG

Thirty patients (suspected of ccRCC) will be included in whom conventional diagnostics are inconclusive. During a multidisciplinary team (MDT) the hypothetical next step in the clinical process will be noted. Subsequently, in these patients a Zirconium-89-girentuximab PET/CT will be performed 4-5 days after single intravenous injection of 5 mg Zirconium-89-girentuximab (37 MBq). The results of the PET/CT will be discussed during the MDT and will be used to decide what the next step in the clinical process will be. This step will be compared with the hypothetical next step from the MDT before the scan. Whether or not the PET/CT scan had impact on clinical decision making will be assessed for each individual patient.

Also known as: girentuximab

Zirconium-89 girentuximab PET/CT

Eligibility Criteria

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

You may qualify if:

• In order to participate in this study, a subject must meet all of the following criteria:
• His or her clinician should face a diagnostic dilemma; e.g.
• patients with a renal mass of unknown origin, or
• patients with a primary renal mass in whom it is unclear whether there is metastatic disease, or
• patients with a history of clear cell RCC with a suspicion of relapse or metastatic disease.
• Minimum age 18 years
• Signed informed consent

You may not qualify if:

• History of a CAIX-negative or non 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 or lactation.
• Known hypersensitivity or HACA (human anti chimeric antibodies) against Girentuximab.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

G250 monoclonal antibody

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

Study Officials

• Wim JG Oyen, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Peter FA Mulders, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: December 1, 2015
• Primary Completion: June 6, 2017
• Study Completion: June 6, 2017
• Last Updated: June 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)