Perfusion CT Scans for Kidney Cancer

Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special type of CT scan, called dynamic contrast enhanced CT (DCE-CT), can determine the effectiveness of certain kidney cancer treatments. It is part of a larger study where patients receive one of three study drugs: everolimus, bevacizumab, or pazopanib, all targeting advanced kidney cancer. Suitable candidates for this trial have metastatic renal cell carcinoma (kidney cancer that has spread) and are either already participating in or considering the related study. The trial involves scanning before and after treatment to assess cancer response. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

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 prior data suggests that perfusion CT scans are safe for kidney cancer patients?

Research has shown that perfusion CT scans, which use a special imaging technique with a contrast dye, are generally safe for most people. Studies have found that the risk of kidney damage from the dye is low, particularly when kidney function, measured by creatinine levels, is normal.

For individuals with normal kidney function, the likelihood of sudden kidney damage from the dye is similar to those who don't receive it. However, about 11% of sudden kidney damage cases from medical procedures involve this type of dye. This indicates that while most people handle the procedure well, a small risk remains.

Prospective trial participants considering perfusion CT scans should understand these facts to weigh the benefits and risks. Discuss any concerns with a healthcare provider, especially if existing kidney issues are present.12345

Why are researchers excited about this trial?

Researchers are excited about using perfusion CT scans for kidney cancer because these scans can provide a detailed picture of blood flow in tumors. Unlike standard imaging options, which typically focus on the size and shape of tumors, perfusion CT scans offer insights into how well blood is reaching the tumor tissue. This information could help doctors determine how a tumor is responding to treatment much earlier than traditional methods. By potentially predicting treatment success or failure sooner, this approach could lead to more personalized and effective treatment plans for patients with kidney cancer.

What evidence suggests that DCE-CT scans are effective for assessing kidney cancer treatment?

Research has shown that a special type of CT scan, called a dynamic contrast-enhanced CT (DCE-CT) scan, can detect changes in blood flow in kidney tumors. These changes are important because they can indicate if a treatment is effective. Studies have found that DCE-CT scans can predict long-term outcomes for patients with metastatic kidney cancer. In this trial, participants will undergo DCE-CT scans 4 weeks before and 8 weeks after starting treatment. The scans measure blood flow and volume in the tumor, which can signal how the cancer might respond to treatments like everolimus, bevacizumab, or pazopanib. Overall, DCE-CT is a promising tool for assessing the effectiveness of cancer treatments.46789

Who Is on the Research Team?

CN

Chaan Ng, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with metastatic renal cell carcinoma who are enrolled or considering enrollment in the START trial. They must have good kidney function, not be pregnant or breastfeeding, and can't join if they've had recent radiotherapy to the tumor area or are allergic to CT contrast media.

Inclusion Criteria

My kidney function is within the normal range.
Patient must be enrolled or being considered for enrollment on protocol 2010-0085.
My cancer is advanced kidney cancer that has spread.

Exclusion Criteria

I am a woman who can have children and have a recent negative pregnancy test.
I am allergic to CT scan dye and need steroids before the scan.
I haven't had radiotherapy on the main cancer spot in the last 4 weeks.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Pre-Treatment Assessment

DCE-CT scan performed to check the status of the disease before starting treatment on study 2010-0085

1 week
1 visit (in-person)

Treatment

Participants receive treatment as part of study 2010-0085 and undergo DCE-CT scan 8 weeks after starting treatment

8 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Perfusion CT scan
Trial Overview The study tests whether a special type of CT scan called dynamic contrast enhanced computed tomography (DCE-CT) can determine how well treatments like everolimus, bevacizumab, or pazopanib are working in patients with advanced kidney cancer.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: DCE-CT ScansExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Early Changes in CT Perfusion Parameters: Primary Renal ...We determined if early changes in perfusion differ between primary renal tumors and metastatic tumor sites in patients with renal cell carcinoma (RCC)
Tumor perfusion assessed by dynamic contrast-enhanced ...In this study, the perfusion and tissue–blood ratio of untreated renal cell carcinomas were examined by DCE MRI. Consecutively, both parameters were compared ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/34535355/
Dynamic contrast-enhanced CT-derived blood flow ...Dynamic contrast-enhanced CT-derived blood flow measurements enable early prediction of long term outcome in metastatic renal cell cancer ...
Blood Volume as a new functional image-based biomarker ...Dynamic contrast-enhanced computed tomography as a potential biomarker in patients with metastatic renal cell carcinoma: preliminary results ...
Dynamic CT Evaluation of Tumor Vascularity in Renal Cell ...The purpose of our study was to evaluate the correlation between the enhancement parameters of dynamic CT; the carcinoma tissue microvessel density (MVD)
Side Effects of Radiographic Contrast Media: Pathogenesis ...The incidence of acute kidney injury in the low-osmolar contrast medium group paralleled that of the control group up to a creatinine level of 1.8 mg/dL, but ...
Study Details | Perfusion Magnetic Resonance Imaging in ...This pilot clinical trial studies perfusion magnetic resonance imaging in diagnosing patients with kidney tumors. Diagnostic procedures, such as perfusion ...
Renal Safety of CT Angiography and Perfusion Imaging in ...This study estimates the renal safety of emergent contrast-enhanced CT imaging in acute stroke patients, when patients without an available serum creatinine ...
Acute kidney injury from contrast-enhanced CT procedures ...However, it has been estimated that acute kidney injury (AKI) due to the injection of iodinated CM accounts for 11% of all cases of AKI, and it is reported in ...
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