NCT03403127

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable lung-cancer

Status
completed

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

May 20, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2013

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

4.8 years

First QC Date

January 11, 2018

Last Update Submit

August 13, 2020

Conditions

Lung CancerNon-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (8)

  • GTV volumes

    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

    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

    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

    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

    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans

    2 weeks post RT Treatment

  • GTV Volumes

    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans

    4 weeks post RT Treatment

  • GTV Volumes

    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans

    7 weeks post RT Treatment

  • GTV volumes

    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans

    3 months post RT treatment

Interventions

PET/CT ScansDIAGNOSTIC_TEST

PET Imaging requires the use of an investigational drug, a radioactively-labelled sugar called 18F-Fluorodeoxyglucose (FDG). FDG is glucose labelled with a radioactive fluorine atom. It is given by intravenous injection and is particularly absorbed by cancer cells. The radioactive signal given off by the FDG can then be detected by the PET scanner providing an image of the cancer (or tumour).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 18, 2018

Study Start

May 20, 2008

Primary Completion

March 25, 2013

Study Completion

April 28, 2020

Last Updated

August 14, 2020

Record last verified: 2020-08