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Efficacy of Ultrasound Contrast Agent to Assess Renal Masses

University Health Network, Toronto logo

University Health Network, Toronto

Status and phase

Completed
Phase 2

Conditions

Renal Cell Carcinoma

Treatments

Drug: Definity

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01062178
08-0512-CE

Details and patient eligibility

About

Patients with an incidentally discovered small renal masses (SRM) < 4 cm in diameter are included. All patients will undergo biopsy for tissue diagnosis. Most patients will be followed by imaging. Study intervention includes low MI US to be performed following both bolus and infusion injection of Definity contrast. Presence and absence of vascularity, pattern of vascularity, and TIC values will be correlated with the final pathology to find features differentiating benign from malignant masses.

Enrollment

167 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Patients with newly diagnosed Renal mass < 4 cmm, who are going to undergo diagnostic CT, MRI or biopsy.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

167 participants in 1 patient group

comparison to biopsy
Experimental group
Description:
Comparing contrast enhanced US with biopsy result
Treatment:
Drug: Definity

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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