NCT00953446

Brief Summary

The purpose of this study is to assess magnetic resonance imaging (MRI) as a tool to track tumor growth for renal cell carcinoma while participants are on clinical treatment therapy of sunitinib and AMG386. An MRI is a type of scan that uses powerful magnets to make clearer images or to focus on detailed medical information in the abdomen and pelvis. The imaging done for this study will use the arterial spin labeling (ASL) MRI technique that allows us to see blood flow changes which possibly may indicate changes in tumor growth. Participants will be on a clinical trial for the treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

June 15, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2011

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

August 5, 2009

Last Update Submit

June 26, 2020

Conditions

Renal Cell Carcinoma

Keywords

metastatic renal cell carcinomaASL MRIsunitinibAMG386

Outcome Measures

Primary Outcomes (4)

  • To explore the association of baseline blood flow in renal cell carcinoma(RCC) measured by ASL MRI and tumor response to treatment with the combination of sunitinib and AMG386

    2 years

  • To explore the association of changes in tumor blood flow that occur early in the course of therapy compared to baseline and response of RCC to treatment with the combination of sunitinib and AMG386

    2 years

  • To evaluate the association between changes in tumor blood flow on ASL over the course of therapy and at the time of disease progression and resistance to therapy.

    2 years

  • To compare above results to those observed in a comparable patient population receiving sunitinib alone.

    2 years

Study Arms (1)

Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging

EXPERIMENTAL

* ASL MRI * Performed at baseline, 2 weeks upon initiation of therapy, after cycle 2 and/or cycle 4 of therapy, and at the end of treatment

Procedure: Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging

Interventions

Arterial Spin Labeling Blood Flow Magnetic Resonance ImagingPROCEDURE

Performed at baseline, 2 weeks upon initiation of therapy, after cycle 2 and/or cycle 4 of therapy, and at the end of treatment

Also known as: ASL MRI
Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18 years
  • Patients diagnosed with metastatic renal cell carcinoma and who will initiate therapy with the combination of sunitinib and AMG386 as either their first anti-angiogenic therapy or after failure of prior cytokine therapy
  • Enrolled on protocol 06-105, "Collection of specimens and clinical data from patients with renal cell carcinoma treated with targeted therapies"
  • Found to have tumors that are \>/=2.5 cm as determined by CT imaging
  • Candidate lesions for ASL MRI should be \>/= 2.5cm. Order of preference of lesion location will be as follows: abdominal lesions, bone lesions and chest lesions

You may not qualify if:

  • Subjects will be excluded from the study if they have a contraindication to MRI which may include the following: Pacemaker, MRI incompatible metal implant, recently implanted vascular clip, history of claustrophobia, metal fragment within the eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Ivan Pedrosa, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

June 15, 2010

Primary Completion

September 13, 2011

Study Completion

September 13, 2011

Last Updated

June 30, 2020

Record last verified: 2020-06

Locations

US(2)