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Completed

NCT Number: NCT03403127

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

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET/CT Scans

Diagnostic 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).

Primary outcomes

  1. 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. 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

  3. 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

  4. 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

  5. GTV volumes

    Time frame: 2 weeks post RT Treatment

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

  6. GTV Volumes

    Time frame: 4 weeks post RT Treatment

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

  7. GTV Volumes

    Time frame: 7 weeks post RT Treatment

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

  8. GTV volumes

    Time frame: 3 months post RT treatment

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2020
First posted
Jan 18, 2018
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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