Perfusion CT Scans for Kidney Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Lactation, Allergy to CT contrast, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a companion protocol to MD Anderson Cancer Center study 2010-0085 (Sequential Therapy in Advanced Renal Cell Carcinoma Therapy: The "START" Trial). The goal of this clinical research study is to learn if dynamic contrast enhanced computed tomography (DCE-CT) scans can help researchers learn if the study drug received as part of study 2010-0085 (either everolimus, bevacizumab, or pazopanib) is working.

Research Team

Chaan Ng, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: DCE-CT Scans Experimental Treatment 1 Intervention

DCE-CT = Dynamic contrast enhanced CT - DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+