Renal Cell CarcinomaNCT02687139
Study of PSMA-targeted 18F-DCFPyL PET/CT in the Evaluation of Patients With Renal Cell Carcinoma
A study testing 18F-DCFPyL and PET/CT in people with Renal Cell Carcinoma and Kidney Cancer, run by Johns Hopkins University at 1 site in United States.
Trial summary
In this study the investigators aim to evaluate diagnostic utility of prostate-specific membrane antigen (PSMA)-targeted 18F-DCFPyL PET/CT in patients with renal cell carcinoma (RCC). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Renal Cell Carcinoma, Kidney Cancer
- What is being tested?
- 18F-DCFPyL and PET/CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed or histologically proven stage II-IV renal cell carcinoma
- Completed staging evaluation with computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen and pelvis ≤90 days prior to study enrollment
Who cannot join
- History of other malignancy diagnosed within the last 3 years (with the exception of low risk prostate cancer, ductal carcinoma in situ of the breast, squamous cell carcinoma or basal cell carcinoma of the skin)
- Administered a radioisotope within 5 physical half-lives prior to study enrollment
- Pregnancy ((as determined in accordance with the policies of the positron emission tomography (PET) center))
- Intention to enroll in a blinded therapeutic clinical trial following Positron emission tomography-computed tomography (PET/CT)
Trial locations and contacts
1 site in 1 country.
About this study
In this study the investigators aim to evaluate diagnostic utility of prostate-specific membrane antigen (PSMA)-targeted 18F-DCFPyL PET/CT in patients with renal cell carcinoma (RCC).
- Conditions
- Renal Cell Carcinoma, Kidney Cancer
- Being tested
- 18F-DCFPyL, PET/CT
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DCFPyLDrug
PET/CTProcedure or surgery
Positron Emission Tomography - Computed Tomography (PET/CT)
| Study group | Role | What they receive |
|---|---|---|
| 18F-DCFPyL PET/CT | Experimental | Not described Receives: Drug: 18F-DCFPyL; Procedure: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC)
This was assessed to compare the sites of disease images of patients with RCC on conventional imaging with the images on the 18F-DCFPyL PET/CT to evaluate the sensitivity of DCFPyL PET/CT scans in detecting sites of disease compared to conventional imaging.
Measured: 12 Months
Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging
This was assessed to Correlate Sites of Radiotracer Uptake on 18F-DCFPyL PET/CT With Conventional Imaging Findings.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies 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
- 34 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
- NCT02687139
- Sponsor's protocol ID
- IRB00075596
- Status last verified
- Apr 2020
- First submitted
- 11 Feb 2016
- Last updated
- 29 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Meyer AR, Carducci MA, Denmeade SR, Markowski MC, Pomper MG, Pierorazio PM, Allaf ME, Rowe SP, Gorin MA. Improved identification of patients with oligometastatic clear cell renal cell carcinoma with PSMA-targeted 18F-DCFPyL PET/CT. Ann Nucl Med. 2019 Aug;33(8):617-623. doi: 10.1007/s12149-019-01371-8. Epub 2019 May 30.
PubMed 31147927
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of PSMA-targeted 18F-DCFPyL PET/CT in the Evaluation of Patients With Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02687139
- Acronym / sponsor ID
- IRB00075596
- Conditions
- Renal Cell Carcinoma, Kidney Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Posted 29 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators aim to evaluate diagnostic utility of prostate-specific membrane antigen (PSMA)-targeted 18F-DCFPyL PET/CT in patients with renal cell carcinoma (RCC).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-DCFPyL PET/CT | Experimental | Drug: 18F-DCFPyL, Procedure: PET/CT |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically diagnosed or histologically proven stage II-IV renal cell carcinoma
- Completed staging evaluation with computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen and pelvis ≤90 days prior to study enrollment
Key exclusion criteria (4 listed)
- History of other malignancy diagnosed within the last 3 years (with the exception of low risk prostate cancer, ductal carcinoma in situ of the breast, squamous cell carcinoma or basal cell carcinoma of the skin)
- Administered a radioisotope within 5 physical half-lives prior to study enrollment
- Pregnancy ((as determined in accordance with the policies of the positron emission tomography (PET) center))
- Intention to enroll in a blinded therapeutic clinical trial following Positron emission tomography-computed tomography (PET/CT)
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 |
|---|---|---|
| 18F-DCFPyL | Drug | 18F-DCFPyL PET/CT |
| PET/CTPositron Emission Tomography - Computed Tomography (PET/CT) | Procedure or surgery | 18F-DCFPyL PET/CT |
Primary outcome
Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC)
Time frame: 12 Months
This was assessed to compare the sites of disease images of patients with RCC on conventional imaging with the images on the 18F-DCFPyL PET/CT to evaluate the sensitivity of DCFPyL PET/CT scans in detecting sites of disease compared to conventional imaging.
Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging
Time frame: 12 Months
This was assessed to Correlate Sites of Radiotracer Uptake on 18F-DCFPyL PET/CT With Conventional Imaging Findings.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31147927Meyer AR, Carducci MA, Denmeade SR, Markowski MC, Pomper MG, Pierorazio PM, Allaf ME, Rowe SP, Gorin MA. Improved identification of patients with oligometastatic clear cell renal cell carcinoma with PSMA-targeted 18F-DCFPyL PET/CT. Ann Nucl Med. 2019 Aug;33(8):617-623. doi: 10.1007/s12149-019-01371-8. Epub 2019 May 30.
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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.
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 18F-DCFPyL and PET/CT in people with Renal Cell Carcinoma and Kidney Cancer, 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 2 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 29 Apr 2020. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02687139, which also lists 1 linked publication.
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 29 Apr 2020.