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

Primary Purpose

Non Small Cell Lung Cancer (NSCLC)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FLT-PET
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non Small Cell Lung Cancer (NSCLC) focused on measuring Stereotactive Body Radiation Therapy (SBRT), Lung Fibrosis, FLT-PET, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLT-PET

Arm Description

Cohort 1: Patients in this cohort would be treatment naïve and will be planned for SBRT treatment according to established institutional practices. FLT-PET in this subgroup will be performed before radiation therapy. Cohort 2: Patients who have had SBRT and demonstrate typical or stable lung fibrosis on follow up CT Cohort 3: Patients who have had SBRT and demonstrate findings suspicious for recurrence on follow up CT or who have biopsy demonstrating disease recurrence.

Outcomes

Primary Outcome Measures

To report the SUVmax for the three cohorts

Secondary Outcome Measures

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

Full Information

First Posted
May 26, 2015
Last Updated
March 21, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02456246
Brief Title
Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT
Acronym
SBRT FLT-PET
Official Title
Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
February 24, 2023 (Actual)
Study Completion Date
February 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer (NSCLC)
Keywords
Stereotactive Body Radiation Therapy (SBRT), Lung Fibrosis, FLT-PET, NSCLC

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FLT-PET
Arm Type
Experimental
Arm Description
Cohort 1: Patients in this cohort would be treatment naïve and will be planned for SBRT treatment according to established institutional practices. FLT-PET in this subgroup will be performed before radiation therapy. Cohort 2: Patients who have had SBRT and demonstrate typical or stable lung fibrosis on follow up CT Cohort 3: Patients who have had SBRT and demonstrate findings suspicious for recurrence on follow up CT or who have biopsy demonstrating disease recurrence.
Intervention Type
Procedure
Intervention Name(s)
FLT-PET
Intervention Description
Positron emission tomography scan using the 18f-FLT (3'deoxy-3'-fluorothymidine) tracer
Primary Outcome Measure Information:
Title
To report the SUVmax for the three cohorts
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To compare FLT uptake in 4D (respiratory sorted) versus free breathing FLT-PET scans
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meredith Giuliani, MD
Organizational Affiliation
UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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