Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT

Non Small Cell Lung Cancer (NSCLC) Clinical Trial

— SBRT FLT-PET  

Official title:

Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456246
• Other study ID #: UHN REB 15-8972-CE
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: February 24, 2023

Study information

• Verified date: March 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stereotactic body radiotherapy (SBRT) has emerged as one of the leading curative method for early stage non-small cell lung cancer (NSCLC). However, assessing the status of the disease during post-SBRT follow up presents a challenge. Currently, chest Computed Tomography (CT) is the main technique to detect whether cancer has come back, but this method has demonstrated poor accuracy and reliability in determining if the observed post-operative lung changes are benign or malignant.

Positron-emission tomography (PET) is an imaging technique that uses special radioactive tracers to cell growth. The use of PET scans with a tracer that target the pathways of DNA synthesis may be more accurate than CT for detecting if the cancer has come or not.

The purpose of this study is to see if a PET radiotracer called 18F-FLT (3'-deoxy-3'-fluorothymidine) can identify cancer recurrences accurately compared to regular CT scans.

Description:

Stereotactic body radiotherapy (SBRT) has demonstrated an impressive 3-year control rate of higher than 90% for early stage NSCLC, leading to increased use of this technique as a curative method for lung cancer treatment. With growing clinical experience with this technique, post-SBRT follow up has received more attention. Follow up after SBRT is done primarily by thorax CT, which is affected by radiation-induced radiographic lung changes that can resemble or obscure local recurrence.

FLT (3'-deoxy-3'-fluorothymidine) is a thymidine analogue which is non-toxic in tracer doses, and can be labeled with 18F. FLT-PET is a type of imaging (similar concept to the widely used 18-FDG PET-CT) that is based on integration of thymidine into DNA for assessment of proliferation. Conceptually, increased DNA synthesis is correlated to tumor aggressiveness and response to therapy, more so than glucose utilization - as in FDG-PET could be.

The purpose of this study is therefore to see what added information the use of FTL-PET can provide in distinguishing between changes in the lung that occur as a result of treatment that are not cancerous and those that are due to recurrence or progressive disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 24, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Must have been treated at or plan to be treated at Princess Margaret Cancer Centre with SBRT for an early-stage NSCLC (T1N0M0; T2N0M0; or T3N0M0 chest wall primary tumours only) and are either:

1. Prior to treatment with lung SBRT (for Cohort 1)

2. Have radiographic findings on that are felt to be related to fibrosis at any time point following lung SBRT

3. Have radiographic findings on CT that are suspicious for recurrence at any time point following lung SBRT

3. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

1. Previous systemic therapy

2. Previous thoracic radiotherapy(excluding the index lung SBRT treatment)

3. Active malignancy other than lung cancer

4. Unable to remain supine for more than 30 minutes

5. If taking the drug Antabuse

6. Pregnancy

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer (NSCLC)

Intervention

Procedure:
• FLT-PET
Positron emission tomography scan using the 18f-FLT (3'deoxy-3'-fluorothymidine) tracer

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To report the SUVmax for the three cohorts		1 year
Secondary	To compare FLT uptake in 4D (respiratory sorted) versus free breathing FLT-PET scans		1 year