Follow up After Cryoablation of Small Renal Masses.

Carcinoma, Renal Cell Clinical Trial

Official title:

Follow up After Percutaneous MR-guided Cryoablation of Small Renal Masses.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411968
• Other study ID #: NL48292.091.14
• Status: Completed
• Start date: February 2015
• Est. completion date: September 2018

Study information

• Verified date: January 2019
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Currently there is no consensus on post procedural follow up imaging following percutaneous cryoablation of renal tumors. Interpretation of conventional contrast enhanced imaging (CT and MRI) during follow up can be very challenging. The objective of this study is to evaluate the feasibility of early evaluation of the therapeutic effect by performing early follow up imaging after percutaneous MR-guided cryoablation of pT1a renal cell carcinoma using 111In-Girentuximab-DOTA SPECT CT imaging.

Description:

With the growing number of small renal masses (SRMs) detected, a growing interest in minimal invasive treatment options for these lesions is seen as they come with several advantages compared to partial nephrectomy. Current guidelines state that patients with a small renal mass unfit to undergo surgery, should be considered for minimal invasive ablative treatment. Although percutaneous cryoablation is shown to be a safe and effective therapy for SRM, there is no consensus on post procedural follow up imaging which should be aimed at evaluation of therapeutic effect of the intervention and the early detection of residual and recurrent disease. Also interpretation of conventional contrast enhanced imaging (CT and MRI) during follow up can be very challenging due to contrast enhancement not necessarily indicating residual or recurrent disease.

The objective of this study is to evaluate the feasibility of early evaluation of the therapeutic effect by performing early follow up imaging after percutaneous MR-guided cryoablation of pT1a renal cell carcinoma 111In-Girentuximab-DOTA SPECT CT imaging.

Therefore, before cryoablation, a targeting 111In-Girentuximab-DOTA SPECT CT scan is performed. Additional functional 111In-Girentuximab-DOTA SPECT CT scan 4-6 weeks after percutaneous MR-guided cryoablation of small renal masses is performed. The latter will take place in case of proven targeting on the pre procedural 111In-Girentuximab-DOTA SPECT CT scan. Standard 1 and 3 months follow up MRI after treatment is performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• >50 years of age;

• At least one untreated T1a tumour of one kidney (tumour = 4 cm in greatest dimension);

• Signed IRB-approved informed consent form.

Exclusion Criteria:

• Pregnancy or breast feeding;

• Known hypersensitivity or HACA against Girentuximab.

• Administration of experimental medication for imaging purposes within three months before administration of Indium-111-Girentuximab for this study, except the administration of Girentuximab labeled with a random isotope.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Intervention

Other:
• 111In-Girentuximab DOTA SPECT

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive value.	Positive predictive value and negative predictive value of 111In-Girentuximab-DOTA SPECT 4-6 weeks after intervention as confirmed on subsequent conventional follow up imaging (contrast enhanced MRI).	Up to at least 3 months following initial treatment (cryoablation).