NCT02558205

Brief Summary

The purpose of this study is to see if it is possible to establish a relationship between the blood flow and blood volume of liver tumors from CT body perfusion and the radiation dose deposited in the tumors from the radioembolization treatment as measured by PET/CT. The study will do this by:

  1. 1.Measuring the blood flow and blood volume of tumors in the imaging data from a CT body perfusion
  2. 2.Measuring the radioactivity in the tumors after the radioembolization treatment using PET/CT and then calculating the dose deposited in the tumor
  3. 3.Using statistical analysis to assess the relationship between the dose and the perfusion parameters

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

5 years

First QC Date

September 22, 2015

Last Update Submit

October 5, 2020

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Correlation of CT perfusion metrics to radiation dose deposition of Y-90 as measured by PET/CT

    1 year

Secondary Outcomes (1)

  • Correlation between CT perfusion metrics and post treatment response as measured by RECIST 1.0 criteria

    2 years

Study Arms (1)

CT Perfusion and PET/CT

Patients undergo both a CT liver perfusion study pre Y-90 treatment and a PET/CT of liver following Y-90 treatment. For the PET/CT no additional radioactivity is required.

Radiation: CT Liver PerfusionRadiation: PET/CT of liver

Interventions

CT Liver PerfusionRADIATION

Imaging study of liver using injection of Iodine contrast agent done using CT imaging

CT Perfusion and PET/CT
PET/CT of liverRADIATION

PET/CT of liver following Y-90 treatment. PET/CT imaging uses positron decay of Y-90 to detect distribution of Y-90 in the liver.

CT Perfusion and PET/CT

Eligibility Criteria

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

Patients identified for Y-90 transarterial radioembolization of liver tumors with hepatocellular carcinoma

You may qualify if:

  • Hepatocellular Carcinoma diagnosis
  • Candidate for Trans-Arterial Radioembolization treatment

You may not qualify if:

  • Less than 18 years old
  • Pregnant
  • Iodinated Contrast Agent Allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

  • Frampas E, Lassau N, Zappa M, Vullierme MP, Koscielny S, Vilgrain V. Advanced Hepatocellular Carcinoma: early evaluation of response to targeted therapy and prognostic value of Perfusion CT and Dynamic Contrast Enhanced-Ultrasound. Preliminary results. Eur J Radiol. 2013 May;82(5):e205-11. doi: 10.1016/j.ejrad.2012.12.004. Epub 2012 Dec 28.

    PMID: 23273822BACKGROUND

  • Morsbach F, Sah BR, Spring L, Puippe G, Gordic S, Seifert B, Schaefer N, Pfammatter T, Alkadhi H, Reiner CS. Perfusion CT best predicts outcome after radioembolization of liver metastases: a comparison of radionuclide and CT imaging techniques. Eur Radiol. 2014 Jul;24(7):1455-65. doi: 10.1007/s00330-014-3180-3. Epub 2014 May 12.

    PMID: 24817083BACKGROUND

  • Lea WB, Tapp KN, Tann M, Hutchins GD, Fletcher JW, Johnson MS. Microsphere localization and dose quantification using positron emission tomography/CT following hepatic intraarterial radioembolization with yttrium-90 in patients with advanced hepatocellular carcinoma. J Vasc Interv Radiol. 2014 Oct;25(10):1595-603. doi: 10.1016/j.jvir.2014.06.028. Epub 2014 Aug 23.

    PMID: 25156647BACKGROUND

  • Bourgeois AC, Chang TT, Bradley YC, Acuff SN, Pasciak AS. Intraprocedural yttrium-90 positron emission tomography/CT for treatment optimization of yttrium-90 radioembolization. J Vasc Interv Radiol. 2014 Feb;25(2):271-5. doi: 10.1016/j.jvir.2013.11.004.

    PMID: 24461132BACKGROUND

  • D'Arienzo M, Filippi L, Chiaramida P, Chiacchiararelli L, Cianni R, Salvatori R, Scopinaro F, Bagni O. Absorbed dose to lesion and clinical outcome after liver radioembolization with 90Y microspheres: a case report of PET-based dosimetry. Ann Nucl Med. 2013 Aug;27(7):676-80. doi: 10.1007/s12149-013-0726-4. Epub 2013 Apr 20.

    PMID: 23605058BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Mark P Supanich, Ph.D.

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 23, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

US(1)