MedDataX Logo

The Use of Breathing Synchronized CT and PET Scans in Radiation Therapy Treatment Planning

NCT ID: NCT00588328

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to find out whether a new device can help obtain more accurate CT and PET scans of the lungs and chest tumors and the liver and liver tumors to help in delivering radiation therapy. When we breathe, the amount of air in the lung changes. Lung tumors may also move during breathing. Liver tumors may also move with breathing; as the lungs inflate, the liver can be pushed down. A CT scan (a special type of X-ray) is routinely obtained as part of planning for lung or liver radiation therapy. Since patients breathe during this CT scan and their lung or liver tumors move, these CT scans can sometimes be inaccurate. We are now testing a device to only obtain the CT and an additional PET scan while patients are breathing in or out. This will hopefully allow us to deliver radiation with more accuracy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objectives are to measure the amount of tumor motion with respiration, measure changes in tumor definition with breathing synchronized PET compared to standard free breathing PET, and to determine the fraction of patients whose radiation treatment plans would be modified based on this information. Eligible patients are those receiving radiation treatment for thoracic or liver tumors.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Non-Hodgkin's Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

PET/CT scan

Intervention Type DEVICE

PET/CT scans

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PET/CT scan

PET/CT scans

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 18 years old
* Ability to sign informed consent form indicating investigative nature of this study, in keeping with the policies of the hospital.
* Patients must have thoracic disease visible on a Chest CT scan, or liver disease visible on a abdominal CT scan.

Exclusion Criteria

* Pregnant women are ineligible. A pregnancy test will be performed on each fertile premenopausal female prior to entry into the study.
* Patients with thoracic or liver disease that is not visible on CT scan
* Patients who are unable to follow directions either due to language difficulties or hearing impairment.
* Patients who are too ill to hold their breath.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kenneth Rosenzweig, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mskcc.org

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00-008

Identifier Type: -

Identifier Source: org_study_id