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

NCT02456246 | Completed

• 1 other identifier: UHN REB 15-8972-CE
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer (NSCLC)

Keywords

Stereotactive Body Radiation Therapy (SBRT); Lung Fibrosis; FLT-PET; NSCLC

Outcome Measures

Primary Outcomes (1)

• To report the SUVmax for the three cohorts

  1 year

Secondary Outcomes (1)

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

  1 year

Study Arms (1)

FLT-PET

EXPERIMENTAL

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

Interventions

FLT-PET PROCEDURE

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

FLT-PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meredith Giuliani, MD

  UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: May 28, 2015
• Study Start: May 1, 2015
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

CA (1)