NCT01163526

Brief Summary

A research study of liver perfusion (how blood flows to the liver over time). We hope to learn whether perfusion characteristics of liver masses may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

5.8 years

First QC Date

July 14, 2010

Last Update Submit

January 26, 2017

Conditions

Neuroendocrine TumorsBrain (Nervous System) CancersColon/Rectal CancerColon CancerHepatobiliary CancersHepatocellular Carcinoma (Hepatoma)Liver

Outcome Measures

Primary Outcomes (1)

  • Predict RECIST response to treatment

    at 3 months from CT perfusion parameters before and after treatment

Secondary Outcomes (2)

  • Characterize CT perfusion longitudinally in both responders and nonresponders

    1 yr

  • Predict disease progression

    1 yr

Study Arms (4)

neuroendocrine metastases

15 patients with neuroendocrine metastases

Procedure: CT perfusion

colon cancer metastases

15 patients with colon cancer metastases

Procedure: CT perfusion

HCC treated with cyberknife radiation and chemotherapy

15 patients with HCC treated with cyberknife radiation and chemotherapy

Procedure: CT perfusion

HCC treated with Sirsphere embolization and chemotherapy

15 patients with HCC treated with Sirsphere embolization and chemotherapy

Procedure: CT perfusion

Interventions

CT perfusionPROCEDURE
HCC treated with Sirsphere embolization and chemotherapyHCC treated with cyberknife radiation and chemotherapycolon cancer metastasesneuroendocrine metastases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients must be 18 years or older. Patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant.

You may qualify if:

  • Patients who have undergone prior chemotherapy more than one year prior to the study are eligible for enrollment.
  • Patients must be 18 years or older. Patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant.
  • No life expectancy restrictions.
  • ECOG and Karnofsky Performance Status will not be employed.
  • Patients with renal failure are ineligible for this study (Glomerular filtration rate (GFR) must be \> 60)

You may not qualify if:

  • No restrictions regarding use of other investigational agents.
  • Patients with severe contrast allergy are ineligible.
  • Patients who are pregnant or are trying to become pregnant are excluded from this study.
  • Patients who are cancer survivors or Human Immunodeficiency Virus (HIV)-positive will not be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Neuroendocrine TumorsNeurologic ManifestationsNeoplasmsColonic NeoplasmsCarcinoma, Hepatocellular

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialLiver NeoplasmsLiver Diseases

Intervention Hierarchy (Ancestors)

Cytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Aya Kamaya

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 15, 2010

Study Start

September 1, 2010

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations

US(1)