Renal Cell CarcinomaNCT02160600
Dual Energy CT vs Standard Triple Phase CT-A Randomised Control Trial
A study testing Standard multiphase CT and split bolus Dual energy CT in people with Renal Cell Carcinoma and Renal Cysts, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
To compare SBDECT with standard Triple Phase Multi-Detector CT (TPMDCT) in renal mass evaluation in terms of appropriateness of treatment received after diagnosis. To determine SBDECT diagnostic accuracy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Renal Cysts, Transitional Cell Carcinoma
- What is being tested?
- Standard multiphase CT and split bolus Dual energy CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2014to Dec 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected renal masses needing further evaluation with a contrast enhanced CT scan
- Patients who are referred for CT Urography
Who cannot join
- Patients not willing to participate in the study
- Age <18 yrs
- Pregnant females
- Patients with previous h/o serious allergic reactions or Contrast allergy
- Impaired renal function (estimated GFR<45mL/min/mm2)
- Sonographically proven benign renal mass needing no further evaluation
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Role of Split Bolus Dual Energy Single Acquisition CT in Evaluation of Urological Diseases of the Upper Urinary Tract.
To compare SBDECT with standard Triple Phase Multi-Detector CT (TPMDCT) in renal mass evaluation in terms of appropriateness of treatment received after diagnosis. To determine SBDECT diagnostic accuracy.
- Conditions
- Renal Cell Carcinoma, Renal Cysts, Transitional Cell Carcinoma, AML
- Being tested
- Standard multiphase CT, split bolus Dual energy CT
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard multiphase CTOther
split bolus Dual energy CTOther
| Study group | Role | What they receive |
|---|---|---|
| split bolus | Experimental | Patients will undergo diagnostic Split bolus DECT scan Receives: Other: split bolus Dual energy CT |
| Standard | Experimental | Patients will undergo routine multiphase diagnostic CT Receives: Other: Standard multiphase CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriateness of the treatment recieved
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionDec 2016
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.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Dinesh Manoharan, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160600
- Sponsor's protocol ID
- IESC/T-457/29.11.2013
- Status last verified
- Apr 2017
- First submitted
- 7 Jun 2014
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Split Bolus Dual Energy Single Acquisition CT in Evaluation of Urological Diseases of the Upper Urinary Tract.
- ClinicalTrials.gov ID
- NCT02160600
- Acronym / sponsor ID
- IESC/T-457/29.11.2013
- Conditions
- Renal Cell Carcinoma, Renal Cysts, Transitional Cell Carcinoma, AML
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jun 2014 (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.
To compare SBDECT with standard Triple Phase Multi-Detector CT (TPMDCT) in renal mass evaluation in terms of appropriateness of treatment received after diagnosis. To determine SBDECT diagnostic accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| split bolus | Experimental | Other: split bolus Dual energy CTPatients will undergo diagnostic Split bolus DECT scan |
| Standard | Experimental | Other: Standard multiphase CTPatients will undergo routine multiphase diagnostic CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with suspected renal masses needing further evaluation with a contrast enhanced CT scan
- Patients who are referred for CT Urography
Key exclusion criteria (6 listed)
- Patients not willing to participate in the study
- Age <18 yrs
- Pregnant females
- Patients with previous h/o serious allergic reactions or Contrast allergy
- Impaired renal function (estimated GFR<45mL/min/mm2)
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 |
|---|---|---|
| Standard multiphase CT | Other | Standard |
| split bolus Dual energy CT | Other | split bolus |
Primary outcome
Appropriateness of the treatment recieved
Time frame: 1 year
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 27 Apr 2017.
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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 study testing Standard multiphase CT and split bolus Dual energy CT in people with Renal Cell Carcinoma and Renal Cysts, run by All India Institute of Medical Sciences at 1 site in India.
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 2 inclusion and 6 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 27 Apr 2017. 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 India. 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.
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?
Appropriateness of the treatment recieved (time frame: 1 year). 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 27 Apr 2017; AzTrials last refreshed its copy on 31 Oct 2026.