Open-label Pilot Evaluating Renal Lesions w/ Contrast-enhaced US in Patients w/ Renal Cancer

NCT ID: NCT01751529

Last Updated: 2017-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-11-30

Brief Summary

This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced ultrasound when used to evaluate renal lesions in two different populations; patients with known renal tumors (Cohort 1) and patients with a risk factor for renal malignancy in whom their screening ultrasound shows an indeterminate or possibly malignant renal mass (Cohort 2).

Detailed Description

This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced ultrasound using microbubble contrast agent (perflutren lipid; Definity®) when used to evaluate renal lesions in two different populations; patients with known renal tumors (Cohort 1) and patients with a risk factor for renal malignancy in whom their screening ultrasound shows an indeterminate or possibly malignant renal mass (Cohort 2).

Conditions

Kidney Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Contrast-enhanced Ultrasound

Group Type: EXPERIMENTAL

Contrast-enhanced Ultrasound

Intervention Type: PROCEDURE

All patients will undergo a contrast-enhanced ultrasound prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.

Perflutren lipid

Intervention Type: DRUG

All patients will receive a contrast-enhanced ultrasound using microbubble contrast agent (perflutren lipid; Definity®) prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.

Interventions

Contrast-enhanced Ultrasound

All patients will undergo a contrast-enhanced ultrasound prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.

Intervention Type: PROCEDURE

Perflutren lipid

All patients will receive a contrast-enhanced ultrasound using microbubble contrast agent (perflutren lipid; Definity®) prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.

Intervention Type: DRUG

Other Intervention Names

Contrast-enhanced US; Definity®

Eligibility Criteria

Inclusion Criteria

1. Able to provide written informed consent

2. Willing to comply with protocol requirements

3. At least 18 years of age

4. Cohort 1:

• Be eligible for radical or partial nephrectomy or ablative therapy based upon at least one renal lesion identified during previous contrast enhanced CT or MR.

OR

5. Cohort 2:

• High risk group (patient recommended for routine surveillance screening for renal malignancy)
• Have at least one kidney lesion identified but incompletely characterized on a screening US, CT, or MR exam

Exclusion Criteria

1. Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD) requiring oxygen)

2. Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)

3. Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome

4. Active cardiac disease including any of the following:

• Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
• Unstable angina.
• Severe arrhythmia (i.e. ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes).
• Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
• Uncontrolled systemic hypertension (Blood pressure: systolic blood pressure (BP) >150 mm Hg and/or diastolic BP >90 mm Hg despite optimal medical management not controllable by medication to achieve BP <15/90)

5. Is in an intensive care setting

6. Has an unstable neurological disease (e.g recent stroke or TIA symptoms (<3 months)) cerebrovascular accident (including transient ischemic attacks (TIAs) within the 3 months before signing of informed consent

7. Undergone an invasive procedure on kidney lesion (e.g. tissue biopsy, surgery, nonsurgical cytoreductive procedure) in-between identification of lesion via US without contrast and perflutren lipid administration

8. Has previously been entered into this study or has received an investigational drug within the 30 days prior to admission into this study

9. Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as:

• Mental illness
• Drug abuse

10. Female patient who is pregnant or lactating (the possibility of pregnancy has to be excluded by negative serum or urine B-HCG results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimryn Rathmell, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Wui Chong, MBBS, FRCR

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Countries

United States

References

Chang EH, Chong WK, Kasoji SK, Fielding JR, Altun E, Mullin LB, Kim JI, Fine JP, Dayton PA, Rathmell WK. Diagnostic accuracy of contrast-enhanced ultrasound for characterization of kidney lesions in patients with and without chronic kidney disease. BMC Nephrol. 2017 Aug 9;18(1):266. doi: 10.1186/s12882-017-0681-8.

Reference Type: DERIVED

PMID: 28793871 (View on PubMed)

Related Links

http://unclineberger.org/

Lineberger Comprehensive Cancer Center website

http://www.cancer.gov/

National Cancer Institute (NCI) website

Other Identifiers

LCCC 1219

Identifier Type: -

Identifier Source: org_study_id