Skip to main content
OpenTrials
Completed

NCT Number: NCT02456246

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non Small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Fibrosis Lung Diseases Lung Diseases, Interstitial Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • 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:
  • Prior to treatment with lung SBRT (for Cohort 1)
  • Have radiographic findings on that are felt to be related to fibrosis at any time point following lung SBRT
  • Have radiographic findings on CT that are suspicious for recurrence at any time point following lung SBRT
  • Ability to provide written informed consent to participate in the study

Exclusion criteria

  • Previous systemic therapy
  • Previous thoracic radiotherapy(excluding the index lung SBRT treatment)
  • Active malignancy other than lung cancer
  • Unable to remain supine for more than 30 minutes
  • If taking the drug Antabuse
  • Pregnancy

Treatment and study plan

FLT-PET

Procedure

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

Primary outcomes

  1. To report the SUVmax for the three cohorts

    Time frame: 1 year

Secondary outcomes

  1. To compare FLT uptake in 4D (respiratory sorted) versus free breathing FLT-PET scans

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: SBRT FLT-PET

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
May 28, 2015
Registry last updated
Mar 22, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.