Renal Cell CarcinomaPhase 2NCT01062178
Efficacy of Ultrasound Contrast Agent to Assess Renal Masses
A Phase 2 study testing Definity in people with Renal Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Definity
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with newly diagnosed Renal mass < 4 cmm, who are going to undergo diagnostic CT, MRI or biopsy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Accuracy of Contrast Enhanced Ultrasound on Diagnosis of Small Renal Masses and Distinguishing Renal Cell Carcinomas From Other Renal Masses, With Biopsy
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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Definity
- Keywords
- Small renal Mass, Contrast Enhanced Ultrasound, Renal Cell Carcinoma, noninvasive diagnosis of RCC
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefinityDrug
Definity is the contrast agent which is going to be injected in a bolus and infusion forms during the ultrasound performance.
| Study group | Role | What they receive |
|---|---|---|
| comparison to biopsy | Experimental | Comparing contrast enhanced US with biopsy result Receives: Drug: Definity |
What is being measured
The primary outcome is the main question the study is designed to answer.
biopsy
Measured: 12 to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062178
- Sponsor's protocol ID
- 08-0512-CE
- Status last verified
- Mar 2016
- First submitted
- 22 Jan 2010
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Accuracy of Contrast Enhanced Ultrasound on Diagnosis of Small Renal Masses and Distinguishing Renal Cell Carcinomas From Other Renal Masses, With Biopsy
- ClinicalTrials.gov ID
- NCT01062178
- Acronym / sponsor ID
- 08-0512-CE
- Conditions
- Renal Cell Carcinoma
- Keywords
- Small renal Mass, Contrast Enhanced Ultrasound, Renal Cell Carcinoma, noninvasive diagnosis of RCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| comparison to biopsy | Experimental | Drug: DefinityComparing contrast enhanced US with biopsy result |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with newly diagnosed Renal mass < 4 cmm, who are going to undergo diagnostic CT, MRI or biopsy.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DefinityDefinity is the contrast agent which is going to be injected in a bolus and infusion forms during the ultrasound performance. | Drug | comparison to biopsy |
Primary outcome
biopsy
Time frame: 12 to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Definity in people with Renal Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biopsy (time frame: 12 to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.