Renal CancerNCT06116253
Advanced Diffusion Imaging in Renal Cancer Patients
A study testing Magnetic Resonance Imaging (MRI) Scan and Tc-99m Pentetate in people with Renal Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
The objective of this study is to apply advanced diffusion imaging in a two-pronged assessment of renal mass patients: (1) characterization of lesion malignancy and subtype, and (2) prediction of renal function stability or decline following partial nephrectomy. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Renal Cancer
- What is being tested?
- Magnetic Resonance Imaging (MRI) Scan and Tc-99m Pentetate
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal mass patients scheduled for laparoscopic partial nephrectomy.
- eGFR above 30 ml/min/m2.
- Ages 21 to 85
- Must be willing and able to provide consent.
Who cannot join
- All metal implants and dental implants that have ferromagnetic properties and are unsafe at 3.0 T.
- Pregnant women are not eligible for participating in this study.
- Acute claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advanced Diffusion Imaging in Renal Cancer Patients: Oncologic Control and Renal Functional Reserve
The objective of this study is to apply advanced diffusion imaging in a two-pronged assessment of renal mass patients: (1) characterization of lesion malignancy and subtype, and (2) prediction of renal function stability or decline following partial nephrectomy.
- Conditions
- Renal Cancer
- Being tested
- Magnetic Resonance Imaging (MRI) Scan, Tc-99m Pentetate
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI) ScanDevice
Also called Prisma 3T scanner
Participants will undergo a 1-hour research MRI scan.
Tc-99m PentetateDrug
Participants will receive radioisotope (99mTc-DTPA) injection (5 mCi) during 3-5 hour scanning session to estimate measured glomerular filtration rate (mGFR).
| Study group | Role | What they receive |
|---|---|---|
| Renal Mass Patients | Experimental | Patients will be enrolled for 2 MRI visits. These visits will include an approximately 1 hour research MRI scan and a total of between 3 and 5 hours Tc-99m DTPA scan.
In each MRI visit, patients will be scanned for approximately one hour including both standard-of-care clinical sequences and research-based Advanced Diffusion Imaging sequences, on a Prisma 3T MRI scanner. Following the MRI exam or on a day not more than a week after the MRI exam, patients will undergo renal function assessment via Tc-99m DTPA scan and patient's kidneys will be scanned using a gamma camera. Proteinuria will be assessed by standard of care urinalysis of specimens collected at each MRI visit for each patient. Blood test will be performed at each visit to estimate GFR (eGFR) from measurement of serum creatinine. Receives: Device: Magnetic Resonance Imaging (MRI) Scan; Drug: Tc-99m Pentetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery
Intravoxel incoherent imaging-MRI (IVIM-MRI) data will be used to predict lesion type.
Measured: Baseline (1 Week Prior to Operation)
Secondary outcomes (1)
Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery
Results from the Renal Flow and Microstructure AnisotroPy-MRI (REFMAP-MRI) pre-surgical scan will be considered as predictors for either stability in renal function or incremental decline in renal function following surgery that would lead to chronic kidney disease (CKD), as defined by mGFR values and proteinuria status at follow-up.
Post-surgical renal insult will be assessed based on either mGFR decline by over 2 ml/min/1.73 m2 per year or the appearance of proteinuria.
Measured: Up to Year 1 Post-Operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Dec 2022
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Eric Sigmund, PhD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116253
- Sponsor's protocol ID
- 21-01230
- Status last verified
- Apr 2026
- First submitted
- 31 Oct 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This project does not contain provisions for generating public databases of anonymized individual data for future outside research. Consistent with the research plan of our funded study and the associated IRB protocol, the results of the study are made available at the aggregate level in the form of peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Diffusion Imaging in Renal Cancer Patients: Oncologic Control and Renal Functional Reserve
- ClinicalTrials.gov ID
- NCT06116253
- Acronym / sponsor ID
- 21-01230
- Conditions
- Renal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 3 Nov 2023 (actual)
- 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 apply advanced diffusion imaging in a two-pronged assessment of renal mass patients: (1) characterization of lesion malignancy and subtype, and (2) prediction of renal function stability or decline following partial nephrectomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Mass Patients | Experimental | Device: Magnetic Resonance Imaging (MRI) Scan, Drug: Tc-99m PentetatePatients will be enrolled for 2 MRI visits. These visits will include an approximately 1 hour research MRI scan and a total of between 3 and 5 hours Tc-99m DTPA scan. In each MRI visit, patients will be scanned for approximately one hour including both standard-of-care clinical sequences and research-based Advanced Diffusion Imaging sequences, on a Prisma 3T MRI scanner. Following the MRI exam or on a day not more than a week after the MRI exam, patients will undergo renal function assessment via Tc-99m DTPA scan and patient's kidneys will be scanned using a gamma camera. Proteinuria will be assessed by standard of care urinalysis of specimens collected at each MRI visit for each patient. Blood test will be performed at each visit to estimate GFR (eGFR) from measurement of serum creatinine. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Renal mass patients scheduled for laparoscopic partial nephrectomy.
- eGFR above 30 ml/min/m2.
- Ages 21 to 85
- Must be willing and able to provide consent.
Key exclusion criteria (3 listed)
- All metal implants and dental implants that have ferromagnetic properties and are unsafe at 3.0 T.
- Pregnant women are not eligible for participating in this study.
- Acute claustrophobia
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI) ScanAlso: Prisma 3T scannerParticipants will undergo a 1-hour research MRI scan. | Device | Renal Mass Patients |
| Tc-99m PentetateParticipants will receive radioisotope (99mTc-DTPA) injection (5 mCi) during 3-5 hour scanning session to estimate measured glomerular filtration rate (mGFR). | Drug | Renal Mass Patients |
Primary outcome
Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery
Time frame: Baseline (1 Week Prior to Operation)
Intravoxel incoherent imaging-MRI (IVIM-MRI) data will be used to predict lesion type.
1 secondary outcome
Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery
Time frame: Up to Year 1 Post-Operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No. This project does not contain provisions for generating public databases of anonymized individual data for future outside research. Consistent with the research plan of our funded study and the associated IRB protocol, the results of the study are made available at the aggregate level in the form of peer-reviewed publications.
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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.
Eric Sigmund, PhD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) Scan and Tc-99m Pentetate in people with Renal Cancer, run by NYU Langone Health 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery (time frame: Baseline (1 Week Prior to Operation)). 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 May 2026.