Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Renal Cell Carcinoma (RCC) Scramble

NCT01224288 | Active Not Recruiting Phase 3

• 2 other identifiers: 2009-0845NCI-2011-03288
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Cell Carcinoma

Keywords

RCC; Kidney cancer; Metastatic renal cell carcinoma; mRCC; Dynamic contrast enhanced CT; DCE-CT; Tumor perfusion

Outcome Measures

Primary Outcomes (1)

• Tumor Blood Flow (BF) Reduction

  Changes in perfusion parameters assessed at first re-staging (approximately 8 weeks) and shortly after initiating therapy (2 - 7 days), for three different therapies using organ-directed DCE-CT tumor assessments. Tumor BF of index lesions computed using commercially available software (GE CT perfusion) using the same index lesion assessed on follow-up scans.

  From 4 weeks prior to first dose to 8 weeks post treatment

Secondary Outcomes (1)

• Progression Free Survival (PFS)

  3 years

Study Arms (1)

DCE-CT Scans

EXPERIMENTAL

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

Procedure: Perfusion CT scan

Interventions

Perfusion CT scan PROCEDURE

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

DCE-CT Scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be enrolled or being considered for enrollment on protocol 2010-0085.
• Patients must have metastatic renal cell carcinoma (RCC).
• Age \>/= 18 years.
• Subjects must have adequate renal function as defined by serum creatinine \< 1.5x upper limit of normal.

You may not qualify if:

• Radiotherapy: Subjects may not have received prior radiotherapy to the index lesion within 4 weeks
• Female subjects who are pregnant or lactating.
• Female subjects of childbearing potential (unless they have a negative serum or urine pregnancy test within 3 days prior to start of study treatment).
• Allergy to CT contrast media requiring the administration of steroid prophylaxis.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Chaan Ng, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 20, 2010
• Study Start: January 5, 2011
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)