PET CT Re-Planning NSCLC (4DCT-PET)

August 13, 2020 updated by: University Health Network, Toronto

Prospective Study of CT and PET Imaging During a Course of Radical Radiotherapy to Determine the Dosimetric Benefits of Re-Planning in Non-Small Cell Lung Cancer

This study will see whether the addition of more frequent planning CTs during the course of radiation, and of Positron Emission Tomography (PET), a diagnostic test similar to CT, prior to and during a course of radiation may provide information that could potentially be used during the treatment to improve the initial radiation plan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age equal to or more than 18 years old
  • Patients with NSCLC consenting for radiotherapy to the primary tumor and / or mediastinal / hilar lymph nodes. Prescription doses should be 60Gy or higher.
  • Chemo-RT patients of any stage of NSCLC
  • Patients with a measurable tumor on CT scan.
  • Patients who are able to lie supine for two consecutive 25 minutes sessions.

Exclusion Criteria:

  • Trimodality patients who will have surgery within 2 months post RT
  • Previous radiotherapy to intended treatment volumes.
  • Patients with recurrent disease
  • Active malignancy other than lung cancer
  • Pregnancy
  • Failure to provide written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GTV volumes
Time Frame: 2 weeks post RT treatment
The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC.
2 weeks post RT treatment
GTV volumes
Time Frame: 4 weeks post RT Treatment
The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
4 weeks post RT Treatment
GTV volumes
Time Frame: 7 weeks post RT Treatment
The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
7 weeks post RT Treatment
GTV volumes
Time Frame: 3 months post RT treatment
he ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
3 months post RT treatment
GTV volumes
Time Frame: 2 weeks post RT Treatment
The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
2 weeks post RT Treatment
GTV Volumes
Time Frame: 4 weeks post RT Treatment
The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
4 weeks post RT Treatment
GTV Volumes
Time Frame: 7 weeks post RT Treatment
The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
7 weeks post RT Treatment
GTV volumes
Time Frame: 3 months post RT treatment
The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
3 months post RT treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2008

Primary Completion (Actual)

March 25, 2013

Study Completion (Actual)

April 28, 2020

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 11, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-0269

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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