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Perfusion CT Scans for Kidney Cancer

Phase 3
Waitlist Available
Led By Chaan Ng, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have adequate renal function as defined by serum creatinine < 1.5x upper limit of normal.
Age >/= 18 years.
Must not have
Allergy to CT contrast media requiring the administration of steroid prophylaxis.
Female subjects who are pregnant or lactating.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will help researchers learn if DCE-CT scans can be used to see if the study drugs given in the START trial are working.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions to the CT contrast agent used during scans such as mild allergic reactions, nausea, vomiting, itching or hives. Serious side effects are rare but could involve kidney issues due to the contrast material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is within the normal range.
Select...
I am 18 years old or older.
Select...
My cancer is advanced kidney cancer that has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am allergic to CT scan dye and need steroids before the scan.
Select...
I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumor Blood Flow (BF) Reduction
Secondary study objectives
Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DCE-CT ScansExperimental Treatment1 Intervention
DCE-CT = Dynamic contrast enhanced CT - DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perfusion CT scan
2019
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,125 Total Patients Enrolled
Chaan Ng, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
178 Total Patients Enrolled

Media Library

Perfusion CT scan Clinical Trial Eligibility Overview. Trial Name: NCT01224288 — Phase 3
Kidney Cancer Research Study Groups: DCE-CT Scans
Kidney Cancer Clinical Trial 2023: Perfusion CT scan Highlights & Side Effects. Trial Name: NCT01224288 — Phase 3
Perfusion CT scan 2023 Treatment Timeline for Medical Study. Trial Name: NCT01224288 — Phase 3
~4 spots leftby Apr 2025
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