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

Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403127
• Other study ID #: 08-0269
• Status: Completed
• Phase: N/A
• Start date: May 20, 2008
• Est. completion date: April 28, 2020

Study information

• Verified date: August 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 28, 2020
• Est. primary completion date: March 25, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Diagnostic Test:
• PET/CT Scans
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	GTV volumes	The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans	2 weeks post RT Treatment
Primary	GTV Volumes	The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans	4 weeks post RT Treatment
Primary	GTV Volumes	The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans	7 weeks post RT Treatment
Primary	GTV volumes	The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans	3 months post RT treatment