Clinical T1 Renal MassNCT02160925
Study of 99mTc-Sestamibi SPECT/CT Imaging for the Preoperative Diagnosis of Renal Oncocytoma
A study testing Preoperative 99mTc-Sestamibi SPECT/CT in people with Clinical T1 Renal Mass, run by Johns Hopkins University at 1 site in United States.
Trial summary
The objective of this study is to investigate the utility of 99mTc-sestamibi SPECT/CT imaging for the diagnosis of renal oncocytomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical T1 Renal Mass
- What is being tested?
- Preoperative 99mTc-Sestamibi SPECT/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jun 2018
- 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
- Presence of a solid enhancing cT1 renal mass detected on cross-sectional imaging
- Scheduled to undergo surgery with either partial or radical nephrectomy
- Age ≥18 years
Who cannot join
- Pregnancy
- Evidence of nodal or distant metastases
- History of other malignancy with concern for renal metastasis
- Known allergy to technetium or sestamibi
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to investigate the utility of 99mTc-sestamibi SPECT/CT imaging for the diagnosis of renal oncocytomas.
- Conditions
- Clinical T1 Renal Mass
- Being tested
- Preoperative 99mTc-Sestamibi SPECT/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative 99mTc-Sestamibi SPECT/CTOther
| Study group | Role | What they receive |
|---|---|---|
| Preoperative 99mTc-Sestamibi SPECT/CT | Experimental | Not described Receives: Other: Preoperative 99mTc-Sestamibi SPECT/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of preoperative 99mTc-sestamibi SPECT/CT findings with tumor histology following surgical resection.
Measured: Within 2 weeks of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical T1 Renal MassStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamad Allaf, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160925
- Sponsor's protocol ID
- IRB00027784
- Status last verified
- Jul 2019
- First submitted
- 6 Jun 2014
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of 99mTc-Sestamibi SPECT/CT Imaging for the Preoperative Diagnosis of Renal Oncocytoma
- ClinicalTrials.gov ID
- NCT02160925
- Acronym / sponsor ID
- IRB00027784
- Conditions
- Clinical T1 Renal Mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 11 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.
The objective of this study is to investigate the utility of 99mTc-sestamibi SPECT/CT imaging for the diagnosis of renal oncocytomas.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative 99mTc-Sestamibi SPECT/CT | Experimental | Other: Preoperative 99mTc-Sestamibi SPECT/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of a solid enhancing cT1 renal mass detected on cross-sectional imaging
- Scheduled to undergo surgery with either partial or radical nephrectomy
- Age ≥18 years
Key exclusion criteria (4 listed)
- Pregnancy
- Evidence of nodal or distant metastases
- History of other malignancy with concern for renal metastasis
- Known allergy to technetium or sestamibi
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 |
|---|---|---|
| Preoperative 99mTc-Sestamibi SPECT/CT | Other | Preoperative 99mTc-Sestamibi SPECT/CT |
Primary outcome
Correlation of preoperative 99mTc-sestamibi SPECT/CT findings with tumor histology following surgical resection.
Time frame: Within 2 weeks of surgery
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 30 Jul 2019.
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.
Mohamad Allaf, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative 99mTc-Sestamibi SPECT/CT in people with Clinical T1 Renal Mass, run by Johns Hopkins University at 1 site in United States.
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 3 inclusion and 4 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 30 Jul 2019. 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 United States. 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?
Correlation of preoperative 99mTc-sestamibi SPECT/CT findings with tumor histology following surgical resection. (time frame: Within 2 weeks of surgery). 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 30 Jul 2019.