Tracking Renal Tumors After Cryoablation Evaluation

NCT01117779 | Terminated Results DMC

• 1 other identifier: CUC10-RNL02
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 7

Brief Summary

TRACE is an observational, open-label, single-arm, multi-center registry of subjects who have undergone renal lesion cryoablation per their physician's standard of care. Patients 18 years of age or older who have been determined to be an appropriate candidate for cryoablation will be offered enrollment into the registry. Subjects will be observed for five years from the date of their cryoablation procedure.

Conditions

Kidney Neoplasms

Keywords

kidney tumors; renal tumors; renal cell carcinoma; kidney lesions; renal lesions; cryoablation; cryotherapy; cryosurgery

Outcome Measures

Primary Outcomes (9)

• Changes in Lesion Size

  Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals.

  Baseline and months 6, 12, 24, 36, 48 and 60

• Renal Function Status

  Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min

  Baseline and months 6, 12, 24, 36, 48 and 60

• Hospital Stay

  Length of time in hospital is the duration of the patient's in-hospital time measured in hours, from intervention to discharge with the average duration of hospitalization being 2 days but could be much longer.

  Average duration of 2 days or longer

• Post-cryoablation Lesion Recurrence With Enhancement

  Lesions with imaging that showed contrast enhancement based on investigator assessment.

  Months 6, 12, 24, 36, 48 and 60

• Disease-specific Survival Rates

  Disease-specific survival rate is the time in days from cryoprocedure to death due to kidney cancer. Subjects who are alive will be censored at date of their last visit. Subjects who have died from causes other than kidney cancer will be censored at the time of death. Patients are followed up for duration of registry which is 5 years.

  Month 60

• Overall Survival Rates

  Death due to any cause

  Month 60

• Quality of Life Assessment

  QoL SF12 is a health status survey to monitor outcomes in general and specific populations. Scoring system for the SF12 is norm-based scoring (NBS). This rescaling is done by linear transformation.The scale for each component is provided where the min = worst health and max= best health. Scale range (min-max,range): GH 23.9-63.7,39.8; PF 25.6-57.1,31.5 ; RP 23.6-57.5, 33.9; BP 21.7-57.7,36.1; VT 29.4-68.7, 39.4; SF 21.3-56.9,35.6; RE 14.7-56.3,41.6; HM 18.3-64.2,45.9; PCS 9.9-76,66 MCS 3.2-77.9,74.7

  Months 6 and 12

• Development of Metastatic Disease.

  Time between cryotherapy and first evidence of metastatic disease

  Month 60

• Total Number of Recurrences

  Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation).

  Month 60

Secondary Outcomes (2)

• Procedure Method Outcomes

  During the procedure and immediately after it, an average of 2 hours.

• Standard of Care Follow-up Procedures

  These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure

Study Arms (1)

Kidney lesions amenable to cryoablation

Kidney lesions treated with cryoablation.

Device: Cryoablation

Interventions

Cryoablation DEVICE

Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

Also known as: Visual-ICE cryoablation system, SeedNet cryoablation system, PresIce cryoablation system, IceRod cryoablation needle, IceRod PLUS cryoablation needle, IceRod CX cryoablation needle, IceEDGE 2.4 cryoablation needle, IceSphere cryoablation needle

Kidney lesions amenable to cryoablation

Eligibility Criteria

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

Study Population

Academic medical centers and community-based physicians

You may qualify if:

• Patient is at least 18 years of age.
• Patient has a renal lesion suspicious for malignancy.
• Patient is to undergo renal lesion cryoablation via a Galil Medical cryoablation system using Galil Medical needles for treatment of primary or recurrent disease.
• Patient is to be available for long-term follow-up per the enrolling physician's standard care practices.
• Patient has provided written informed consent.

You may not qualify if:

• Patient is either currently using or has used within the last 30 days an investigational product of any type.
• Patient has metastatic disease to or from the kidney.
• Patient has had previous therapy on the index lesion (e.g. radiofrequency, cryoablation, partial nephrectomy).

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (7)

University of California Irvine

Orange, California, 92868, United States

Location

Kaiser Permanente

Denver, Colorado, 80205, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (6)

• Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8.

  PMID: 1387912 BACKGROUND

• Saliken JC, Donnelly BJ, Rewcastle JC. The evolution and state of modern technology for prostate cryosurgery. Urology. 2002 Aug;60(2 Suppl 1):26-33. doi: 10.1016/s0090-4295(02)01681-3.

  PMID: 12206845 BACKGROUND

• Rewcastle JC, Sandison GA, Saliken JC, Donnelly BJ, McKinnon JG. Considerations during clinical operation of two commercially available cryomachines. J Surg Oncol. 1999 Jun;71(2):106-11. doi: 10.1002/(sici)1096-9098(199906)71:23.0.co;2-z.

  PMID: 10389867 BACKGROUND

• Rewcastle JC, Hahn LJ, Saliken JC, McKinnon JG. Use of a moratorium to achieve consistent liquid nitrogen cryoprobe performance. J Surg Oncol. 1997 Oct;66(2):110-3. doi: 10.1002/(sici)1096-9098(199710)66:23.0.co;2-g.

  PMID: 9354166 BACKGROUND

• Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.

  PMID: 10075613 BACKGROUND

• Finley DS, Beck S, Box G, Chu W, Deane L, Vajgrt DJ, McDougall EM, Clayman RV. Percutaneous and laparoscopic cryoablation of small renal masses. J Urol. 2008 Aug;180(2):492-8; discussion 498. doi: 10.1016/j.juro.2008.04.019. Epub 2008 Jun 11.

  PMID: 18550087 BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Chantal Laframboise, Clinical Research Manager
• Organization: Boston Scientific

chantal.laframboise@bsci.com

613-882-0876

Study Officials

• Stephen Savage, MD

  Medical University of South Carolina

  STUDY CHAIR

• Peter Clark, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: July 9, 2010
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: January 19, 2024
• Results First Posted: January 19, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)