ASL-MRI for Kidney Cancer

Overseen By Ananth Madhuranthakam, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Anti-angiogenics, Immunotherapy

Must not be taking: Anti-angiogenics

Disqualifiers: Pregnancy, MRI contraindications, Sickle cell, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 7 months

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Magnetic Resonance Imaging (MRI) including Arterial Spin Labeling (ASL) will be performed before, during, and after the treatment, in a total of up to 6 MRI sessions until 7 months after the first session, or when progression is clinically indicated. Thereafter, patients will be followed through standard clinical examinations for the next 3 years or until demise, whichever occurs first. Clinically, metastatic renal cell carcinoma (RCC) patients are imaged every 2-3 months after the initiation of anti-angiogenic therapy, since morphological (i.e. size) changes are not anticipated earlier. However, our preliminary experience has shown functional changes including perfusion as early as 2-weeks after the initiation of the treatment. T0, T1, and T2 sessions will be performed for this proposal, while T3, T4, and T5 will be performed along with the clinical imaging sessions. All MR imaging sessions will be scheduled within ±1 or ±2 weeks of the target time period. The research MR imaging may take approximately an additional 15 minutes per each imaging session, when done in conjunction with the clinical imaging. The T0, T1, and T2 research MR imaging sessions will be performed additionally for the purpose of this study, with each taking approximately one hour.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any other anti-angiogenic agents when you enroll.

Is ASL-MRI safe for humans?

ASL-MRI is a non-invasive imaging method that has been used safely in healthy volunteers to measure kidney function, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How is ASL-MRI treatment for kidney cancer different from other treatments?

ASL-MRI (Arterial Spin Labeling Magnetic Resonance Imaging) is unique because it uses a non-invasive imaging technique to measure blood flow in the kidneys, which can help differentiate between types of kidney cancer without the need for contrast agents or invasive procedures. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment MRI with ASL for kidney cancer?

The research shows that MRI, including advanced techniques like multiparametric and diffusion-weighted imaging, can help differentiate between types of kidney tumors and assess their growth, which suggests that MRI with ASL might also be effective in evaluating kidney cancer. ^{8 9 11 12 13}

Are You a Good Fit for This Trial?

This trial is for adults with advanced or spreading kidney cancer who are about to start anti-angiogenic treatment or immunotherapy. They must be able to consent, not pregnant, and have an ECOG status of 0-2 (which measures their level of functioning). People can't join if they're on other anti-angiogenic drugs, pregnant, have MRI-incompatible devices in their body, severe allergies to Gadolinium contrast agents, certain blood disorders or conditions that make lying still for an MRI impossible.

Inclusion Criteria

My kidney cancer has spread beyond the kidney.

I am scheduled for treatment that stops tumors from making new blood vessels or boosts my immune system.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You have had a serious allergic reaction to Gadolinium-based contrast agents.

I am not currently taking any medication that stops the formation of new blood vessels.

You cannot have an MRI because you have certain medical devices or objects in your body that are not safe for an MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI sessions including Arterial Spin Labeling (ASL) before, during, and after treatment to assess therapy response

7 months

Up to 6 MRI sessions

Follow-up

Participants are monitored through standard clinical examinations for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• MRI with ASL

Trial Overview The trial tests how well a type of MRI scan called Arterial Spin Labeling (ASL) can track changes in kidney tumors during treatment. Participants will undergo up to six additional MRIs over seven months plus standard follow-ups for three years. The ASL scans may show changes in tumor blood flow as early as two weeks after starting therapy.

How Is the Trial Designed?

Group I: RCC Patients Experimental Treatment 1 Intervention

Patients with locally advanced or metastatic renal cell carcinoma

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

In a study of 33 renal carcinoma cases, both CT and MRI showed similar accuracy in staging early-stage tumors, correctly staging 27 and 28 tumors respectively.

For advanced renal carcinoma, MRI outperformed CT, particularly in accurately diagnosing tumor thrombus, suggesting that MRI could be a better alternative to conventional cavography for assessing tumor extent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The staging of renal-cell carcinomas in MRT and CT--a prospective histologically controlled study]. Hallscheidt, P., Stolte, E., Roeren, T., et al.[2015]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

[The staging of renal-cell carcinomas in MRT and CT--a prospective histologically controlled study]. [2015]

2. Germany pubmed.ncbi.nlm.nih.gov

Routinely performed multiparametric magnetic resonance imaging helps to differentiate common subtypes of renal tumours. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Sarcomatoid renal cell carcinoma: MRI features and their association with survival. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Utility and limitations of 3-Tesla diffusion-weighted magnetic resonance imaging for differentiation of renal tumors. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

The kidney imaging surveillance scoring system (KISSS): using qualitative MRI features to predict growth rate of renal tumors in patients with von-Hippel Lindau (VHL) syndrome. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Arterial spin labeling blood flow magnetic resonance imaging for the characterization of metastatic renal cell carcinoma(1). [2012]

7. England pubmed.ncbi.nlm.nih.gov

Inter-study reproducibility of arterial spin labelling magnetic resonance imaging for measurement of renal perfusion in healthy volunteers at 3 Tesla. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided laser thermal ablation of renal tumours. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of a free-breathing respiratory-triggered (Navigator) 3-D T1-weighted (T1W) gradient recalled echo sequence (LAVA) for detection of enhancement in cystic and solid renal masses. [2021]

10. Japan pubmed.ncbi.nlm.nih.gov

A comparative study between arterial spin labeling and CT perfusion methods on hepatic portal venous flow. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Multiparametric magnetic resonance imaging for the differentiation of low and high grade clear cell renal carcinoma. [2021]

12. China pubmed.ncbi.nlm.nih.gov

[MR imaging features of different renal cell carcinoma subtypes]. [2009]

13. England pubmed.ncbi.nlm.nih.gov

Efficacy of 3D VIBE Dixon fat quantification for differentiating clear-cell from non-clear-cell renal cell carcinoma. [2019]