Follow up After Cryoablation of Small Renal Masses.

NCT02411968 | Completed DMC

• 1 other identifier: NL48292.091.14
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Renal Cell

Keywords

Cryosurgery; Carcinoma, renal cell; Diagnostic Imaging; Diagnostic techniques, urological; Radionuclide imaging; Follow up

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (1)

111In-Girentuximab DOTA SPECT

Patients \>50 years of age with renal tumours ≤4 cm highly suspicious for a malignancy planned to undergo cryotherapy will undergo 111In-Girentuximab DOTA SPECT scanning.

Other: 111In-Girentuximab DOTA SPECT

Interventions

111In-Girentuximab DOTA SPECT OTHER

111In-Girentuximab DOTA SPECT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients \>50 years of age with renal tumours ≤4 cm highly suspicious for a malignancy on imaging requiring treatment and planned to undergo cryotherapy.

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, 6500HB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Needle biopsy kidney tumor.

MeSH Terms

Conditions

Carcinoma, Renal Cell

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

• Jurgen J Futterer, M.D. PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Wim JG Oyen, M.D. PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Peter FA Mulders, M.D. PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 8, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)