NCT01109953

Brief Summary

The patient has been referred for an FDG PET/CT scan. FDG is a form of sugar that contains a small amount of radioactivity; it is used to see the size and possible spread of cancer in the body. Pictures of the body are taken on a machine called a PET/CT scanner. The purpose of this current study is to see if we, the investigators, can take clearer pictures of the tumor than we could with our routine scan method. This would allow us to better see how FDG is picked up by the tumor. PET/CT is presently one of the best tools for detecting cancer and determining its spread in the body. However, due to breathing motion, PET and CT images may become blurred and the location of the tumor on CT and PET images may not match. We have developed a new method that enables us to reduce image blurring and to measure the tumor more accurately on PET images. In this study we want to compare two kinds of images: those from the standard PET/CT scan, and the PET/CT scan pictures taken with our new method. If successful, we may use this new method for clinical routine in the future.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

1.9 years

First QC Date

April 20, 2010

Last Update Submit

March 15, 2012

Conditions

Keywords

LungPET/CT scan10-054

Outcome Measures

Primary Outcomes (1)

  • To determine if our breath-hold acquisition technique can be implemented in whole-body PET/CT scans.

    Because PET events not satisfying the breathing amplitude selection criteria will be dropped off the final image set, it will be necessary to increase the acquisition time for the FOV's covering the thorax area from 3 min/bed to 5 min/bed to compensate for the reduction in statistics. This should result in a total increase of \~6 min for the whole body scan.

    at the time of scan

Secondary Outcomes (1)

  • To determine if whole body PET/CT improves spatial matching of PET and CT

    at the time of scan

Study Arms (1)

Breath-Hold PET/CT image

In addition to the standard clinical PET/CT images, we will provide a breath-hold PET/CT image set, using the same PET data for both.

Other: Breath-Hold PET/CT image set

Interventions

In addition to the standard clinical PET/CT images, we will provide a breath-hold PET/CT image set, using the same PET data for both. In order to spatially match PET, and therefore improve attenuation correction in the PET images, we will acquire a Breath-Hold CT at 310 mA over the same region covered by PET. The normal-organ doses accumulated from the additional 30 mA CT. The patient's breathing signal during CT and the whole body PET will be recorded using a video camera and in house developed software. We will compare the clinical PET/CT and Breath-Hold PET/CT in regards to lesion detection, lesion volume, and SUV quantification.

Breath-Hold PET/CT image

Eligibility Criteria

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

Patients scheduled for whole body FDG PET/CT examination as part of their routine clinical care.

You may qualify if:

  • Participant is capable of providing written consent.
  • years of age or older.
  • Patient with a known or suspected FDG-avid malignancy in the torso

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Heiko Schoder, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 23, 2010

Study Start

April 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations