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

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ClinicalTrials.gov Identifier: NCT02456246
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer (NSCLC) Procedure: FLT-PET Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT
Study Start Date : May 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: FLT-PET
  1. 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.
  2. Cohort 2: Patients who have had SBRT and demonstrate typical or stable lung fibrosis on follow up CT
  3. Cohort 3: Patients who have had SBRT and demonstrate findings suspicious for recurrence on follow up CT or who have biopsy demonstrating disease recurrence.
Procedure: FLT-PET
Positron emission tomography scan using the 18f-FLT (3'deoxy-3'-fluorothymidine) tracer




Primary Outcome Measures :
  1. To report the SUVmax for the three cohorts [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To compare FLT uptake in 4D (respiratory sorted) versus free breathing FLT-PET scans [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456246


Contacts
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Contact: Meredith Giuliani, MD 416 946 4501 ext 2983 Meredith.Giuliani@rmp.uhn.on.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Meredith Giuliani, MBBS,MD,FRCPC    416 946 4501 ext 2983    Meredith.Giuliani@rmp.uhn.on.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Meredith Giuliani, MD UHN

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02456246     History of Changes
Other Study ID Numbers: UHN REB 15-8972-CE
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

Keywords provided by University Health Network, Toronto:
Stereotactive Body Radiation Therapy (SBRT)
Lung Fibrosis
FLT-PET
NSCLC

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms