Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Advanced MRI Imaging for Kidney Cancer?
MRI is effective in diagnosing and staging kidney cancer, as it provides detailed images that help differentiate between cancerous and non-cancerous tumors, assess tumor spread, and monitor treatment progress without using radiation.
12345Is MRI with Gd-DTPA safe for humans?
Gd-DTPA, a contrast agent used in MRI, has been tested in over 13,000 patients and is generally safe, with minor side effects occurring in about 1.46% of cases. It is well-tolerated even in patients with kidney issues, and no critical adverse reactions have been reported.
678910How does the treatment in the Advanced MRI Imaging for Kidney Cancer trial differ from other treatments?
This treatment uses advanced MRI imaging, which provides detailed pictures of kidney tumors without radiation exposure, unlike CT scans. It offers better sensitivity for detecting tumor spread and can be used for patients who cannot tolerate traditional contrast agents.
13111213Eligibility Criteria
This trial is for adults aged 21 to 85 with kidney tumors who are scheduled for a type of surgery called laparoscopic partial nephrectomy. They must have a certain level of kidney function (eGFR above 30) and be able to consent. People with metal or dental implants unsafe in strong magnetic fields, pregnant women, or those with severe claustrophobia cannot join.Inclusion Criteria
Must be willing and able to provide consent
I am scheduled for a partial kidney removal surgery.
My kidney function is above the minimum required level.
+1 more
Exclusion Criteria
You are currently experiencing acute claustrophobia.
Pregnant women are not eligible for participating in this study
You have metal implants or dental implants that can't be used during an MRI scan at a strength of 3.0 Tesla.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-Surgery Assessment
Participants undergo MRI and Tc-99m DTPA scans to characterize lesion malignancy and predict renal function stability or decline
1 week
2 visits (in-person)
Post-Surgery Follow-up
Participants are monitored for renal function stability or decline following partial nephrectomy
Up to 1 year
Participant Groups
The study uses advanced MRI scans and a tracer called Tc-99m Pentetate to assess the nature of kidney tumors and predict changes in kidney function after part of the kidney is surgically removed.
1Treatment groups
Experimental Treatment
Group I: Renal Mass PatientsExperimental Treatment2 Interventions
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
National Institutes of Health (NIH)Collaborator
References
Cross-sectional imaging assessment of renal masses with emphasis on MRI. [2022]Magnetic resonance imaging (MRI) is a useful complementary imaging tool for the diagnosis and characterization of renal masses, as it provides both morphologic and functional information. A core MRI protocol for renal imaging should include a T1-weighted sequence with in- and opposed-phase images (or, alternatively with DIXON technique), T2-weighted and diffusion-weighted images as well as a dynamic contrast-enhanced sequence with subtraction images, followed by a delayed post-contrast T1-weighted sequence. The main advantages of MRI over computed tomography include increased sensitivity for contrast enhancement, less sensitivity for detection of calcifications, absence of pseudoenhancement, and lack of radiation exposure. MRI may be applied for renal cystic lesion characterization, differentiation of renal cell carcinoma (RCC) from benign solid renal tumors, RCC histologic grading, staging, post-treatment follow-up, and active surveillance of patients with treated or untreated RCC.
[The staging of renal-cell carcinomas in MRT and CT--a prospective histologically controlled study]. [2015]To evaluate the accuracy of computed tomography (CT) and magnetic resonance imaging (MRI) in staging renal carcinoma.
[The importance of magnetic resonance tomography in the diagnosis and staging of renal cell carcinoma]. [2006]The use of magnetic resonance imaging (MRI) for diagnosis and preoperative staging of renal cell carcinoma was evaluated in 79 patients with 88 tumors. Gradient-echo and spin-echo images before and after intravenous administration of Gadolinium-DTPA were compared with the results of computed tomography (CT) and histologic staging. The two imaging techniques had comparable results: T-stage was predicted correctly with CT in 78.4% and with MRI in 84.0% of the cases, while the N-stage was accurately assessed in 81.8% and 79.5%, respectively. MRI had some advantages in diagnosing perirenal tumor spread and in excluding an infiltration beyond Gerota's fascia. Therefore, MRI is a true alternative to CT for staging large renal cell carcinomas and especially for patients with contraindications for iodinated contrast agents.
Multiparametric Renal MRI: An Intrasubject Test-Retest Repeatability Study. [2021]Renal multiparametric magnetic resonance imaging (MRI) is a promising tool for diagnosis, prognosis, and treatment monitoring in kidney disease.
Detection and staging of renal cancer. [2005]Although MR imaging is not a first-line modality for detecting renal cancers, it is useful when computed tomography or ultrasound are limited by artifacts or when contrast media cannot be administered because of renal dysfunction or allergy. MR imaging is commonly used in staging renal cancers, particularly in assessing the presence and extent of inferior vena caval thrombus. Additionally, MR imaging can be useful in detecting adenopathy, hepatic metastases, direct organ invasion, and bony metastases to the spine. Thus, MR imaging has an established role in the detection and staging of renal cancers.
Tolerance data of Gd-DTPA: a review. [2022]Gd-DTPA is the first paramagnetic contrast agent approved for clinical use in cranial and spinal MRI in the F.R.G., U.S.A., Japan and several other countries. After submission 13,439 patients were enrolled in standardized protocolled clinical trials. The observed adverse drug reactions (ADRs) after i.v. injection of Gd-DTPA were comparable to those after administration of iodinated non-ionic roentgen contrast media (CM). However, the overall incidence of ADRs after intravenous injection of 0.1 or 0.2 mmol/kg body weight Gd-DTPA was found to be even lower. Adverse events were observed in only 1.46% of the patients - or 1.14% if localized warmth is excluded. None of them was critical. There was no correlation between patient age and the incidence of ADRs. In patients with a known history of allergy the incidence of ADRs was increased by a factor 3-4, which is still lower than the incidence reported after intravenous administration of iodinated non-ionic roentgen CM to patients without known allergy. Good renal tolerance was seen in all patients, irrespective of pre-existing renal impairment. Fast bolus injections of Gd-DTPA were tolerated without added risk. The favorable safety profile is also reflected in the post marketing surveillance reports since Gd-DTPA became available as a commercial drug.
Does gadolinium-diethylene triamine pentaacetic acid enhanced MRI of kidney represent tissue concentration of contrast media in the kidney? In vivo and in vitro study. [2019]Although Gadolinium-diethylene triamine pentaacetic acid (Gd-DTPA) has been used as a contrast material in magnetic resonance imaging (MRI), it is known that contrast enhancement effect is not uniform if the concentration of Gd-DTPA increases beyond some levels. In this study, to evaluate the proper pulse sequences for dynamic MRI in the human kidney, the concentration of Gd-DTPA was quantitatively measured by inductively coupled plasma (ICP) emission spectrometry in human biological samples after administration of Gd-DTPA. The signal intensity of MRI in the solutions of several concentrations of Gd-DTPA was measured. The results were that in using a low magnetic field apparatus, signal intensity linearly correlated with the concentration of Gd-DTPA between 0 and 2.0 mumol/g under saturation recovery sequences (flip angle = 60 degrees or 90 degrees). Using a high magnetic field apparatus, signal intensity linearly correlated with the concentration of Gd-DTPA between 0 and 2.0 or 3.0 mumol/g under spin-echo or gradient-echo sequences. Gd-DTPA concentration of the renal cortex ranged from 0.132 to 0.152 mumol/g tissue at 5 min after IV injection of Gd-DTPA 0.05 mmol/kg body weight in six patients with adrenal tumor or renal cell cancer, and one patient with both urinary bladder cancer and prostatic cancer. Six of the patients showed normal renal function and the other had renal insufficiency (GFR = 25 ml/min/1.48 m2).(ABSTRACT TRUNCATED AT 250 WORDS)
Gd-DTPA as a contrast agent in CT. [2015]An evaluation was done of the effect of gadolinium diethylenetriaminepentaacetic acid (DTPA) on computed tomographic (CT) studies performed after magnetic resonance (MR) imaging. CT scans of two solutions of Gd-DTPA demonstrated substantial attenuation. In two patients who underwent CT after Gd-DTPA-enhanced MR imaging, the high attenuation of concentrated Gd-DTPA was seen in the urinary bladder and renal collecting system. However, in the concentration presently used in MR imaging, Gd-DTPA results in only minor enhancement of renal cortex.
Molecular MRI of the Cardiovascular System in the Post-NSF Era. [2021]Two new molecular MRI agents have been approved for clinical use within the last 3 years, and a third agent has completed phase-2 clinical trials. A wealth of preclinical data is also emerging on the general safety of many molecular MR imaging agents. In addition, since the guidelines to avoid nephrogenic systemic fibrosis (NSF) were adopted, at most institutions no new cases of NSF have been reported. Nevertheless, in the post-NSF environment, both those developing and using molecular MR imaging agents need to be increasingly aware of safety issues. This awareness should begin with the design of the agent and, even in early preclinical studies, the demonstration of safety and efficacy should both be given high priority. In this review we discuss some of the issues relevant to the design of safe molecular MR imaging agents and highlight the excellent safety profile of those agents that have been used clinically to date.
Gadolinium-DTPA enhancement of VX-2 carcinoma of the rabbit kidney on T1 weighted magnetic resonance images. [2015]Experimental renal carcinoma was induced by percutaneous injection of VX-2 carcinoma cells into the left kidney in New Zealand white rabbits. Magnetic resonance imaging (MRI) was performed at 0.15 T before and after intravenous injection of 0.3 mmol gadolinium-DTPA (Gd-DTPA) per kg body weight. Gd-DTPA enhanced the tumors by increasing the signal intensity on T1 weighted images. The enhancement was evident immediately after Gd-DTPA injection, increasing during the observation time of 30 minutes. Histologically the areas of enhancement corresponded well to the viable tumor tissue.
[Clinical value of new rapid nuclear magnetic resonance tomography in preoperative assessment of hypernephroma. A prospective comparative study of CT and MR]. [2015]The new technique of rapid magnetic resonance imaging (MRI) with a paramagnetic contrast agent provides excellent imaging of the kidneys and their lesions. MR imaging of this anatomical region at short breath holding intervals matches the well-known quality of computed tomography (CT) for the first time. MR and CT studies were performed on 36 patients with proven renal cell carcinoma. Different investigators evaluated the staging of the tumor by means of both techniques in a prospective study. In all patients a radical nephrectomy was performed. Surgical and pathological findings were compared. Though little difference was found in diagnostic value between the two systems, MRI results concerning the T-stage were better. Venous invasion was clearly shown by MRI without the use of contrast medium. Furthermore, sagittal and transaxial images provided a more direct assessment of the extent of the tumor and its demarcation to healthy parenchyma. Thus, MRI is helpful in planning of the surgical approach when organ-sparing excision of renal tumors is to be performed.
Magnetic resonance imaging of the kidneys: current status. [2004]Magnetic resonance imaging (MRI) differs fundamentally from other imaging techniques, since for the first time one method permits simultaneous assessment of macroscopic changes in the kidneys and evaluation of renal functional derangements. To provide morphological information that may compete with the results of computed tomography (CT) and ultrasonography (US), special techniques like artifact compensation, fast imaging, and fat suppression have to be employed. The additional use of a renally eliminated paramagnetic contrast agent permits assessment of parenchymal perfusion and visualization of the passage of the contrast medium, providing information about renal excretory function. Results and clinical utility of state of the art MRI can be summarized as follows: (a) MR is not a screening method; sensitivity is, however, similar to CT when fat suppression and contrast agents are used. (b) Classification of renal masses is almost restricted to the differentiation of cystic, fat-containing, and solid lesions. (c) Contrast-enhanced MRI helps to assess large retroperitoneal masses and to classify them as intra- or extrarenal. (d) Accurate staging of renal cancers is possible; thus, MRI is a good alternative when CT yields uncertain findings and for patients with known contraindications to the administration of iodinated contrast agents. (e) Contrast-enhanced dynamic MRI studies provide semiquantitative evaluation of global and segmental renal function. (f) MR angiography offers the possibility to evaluate renal arteries and veins.
MR imaging of renal neoplasms. [2005]MR imaging has many advantages over other modalities in the detection and staging of renal neoplasms, because of its intrinsic high soft tissue contrast, direct multiplanar imaging capabilities, and the availability of a non-nephrotoxic, renally excreted contrast agent. The ongoing refinement of breath-hold imaging sequences will probably broaden the use of MR techniques in imaging renal neoplasms.