- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02456246
Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT (SBRT FLT-PET)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- University Health Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FLT-PET
|
Positron emission tomography scan using the 18f-FLT (3'deoxy-3'-fluorothymidine) tracer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To report the SUVmax for the three cohorts
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare FLT uptake in 4D (respiratory sorted) versus free breathing FLT-PET scans
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 15-8972-CE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Small Cell Lung Cancer (NSCLC)
-
H. Lee Moffitt Cancer Center and Research InstituteNestle Health ScienceWithdrawnNSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | NSCLC Stage IIIB | Non-small Cell Lung Cancer Stage IIIB | NSCLC, Stage IIIA | Non-small Cell Lung Cancer Stage ⅢAUnited States
-
ElephasBeaufort CRORecruitingNSCLC | Non Small Cell Lung Cancer | Metastatic Non Small Cell Lung Cancer | Metastatic NSCLC - Non-Small Cell Lung CancerUnited States
-
Mythic TherapeuticsRecruitingNon-Small Cell Lung Cancer | NSCLC | Advanced Non-Small Cell Lung Cancer | NSCLC Stage IV | NSCLC Stage IIIB | Advanced Non-Small Cell Squamous Lung Cancer | Advanced Non-Small Cell Non-Squamous Lung CancerUnited States, Australia, Korea, Republic of, United Kingdom
-
Jun Zhang, MD, PhDGenentech, Inc.; ExelixisNot yet recruitingLung Cancer | NSCLC Stage IV | Advanced NSCLC | Metastatic NSCLC - Non-Small Cell Lung CancerUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingNSCLC | Non Small Cell Lung Cancer | Non Small Cell Lung Cancer Metastatic | NSCLC Stage IV | Non-small Cell CarcinomaUnited States
-
University of Alabama at BirminghamSanofiCompletedNon-small Cell Lung Cancer (NSCLC) | Metastatic NSCLC | Stage IV NSCLCUnited States
-
Oslo University HospitalAstraZenecaActive, not recruitingCancer | NSCLC | Non Small Cell Lung Cancer | NSCLC, Stage III | Non Small Cell Lung Cancer Stage IIINorway, Finland, Lithuania, Estonia
-
Radiotherapy Oncology Centre "Santa Maria" HospitalPaola Anselmo,MD; Michelina Casale,PhD; Fabio Trippa,MDRecruitingNSCLC | Non Small Cell Lung Cancer | EGF-R Positive Non-Small Cell Lung Cancer | Non Small Cell Lung Cancer Metastatic | NSCLC Stage IV | Oligometastatic Disease | Non-Small Cell Squamous Lung Cancer | Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor | Non-Small Cell Adenocarcinoma and other conditionsItaly
-
Heather WakeleeNovartis; Genentech, Inc.TerminatedNon-small Cell Lung Cancer (NSCLC), Recurrent | Non-small Cell Lung Cancer (NSCLC), Stage IVUnited States
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
Clinical Trials on FLT-PET
-
UNC Lineberger Comprehensive Cancer CenterWithdrawnBrain Metastasis | Brain Metastases | Brain LesionsUnited States
-
Rigshospitalet, DenmarkCompletedSmall Cell Lung Cancer | Lung Cancer, Nonsmall CellDenmark
-
Rigshospitalet, DenmarkCompleted
-
Rigshospitalet, DenmarkTerminated
-
Barbara Ann Karmanos Cancer InstituteChildren's Hospital of MichiganUnknown
-
University of OklahomaMidwest Medical IsotopesTerminatedNon-Hodgkin's LymphomaUnited States
-
University of IowaNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedHead and Neck Neoplasms | Mouth Neoplasms | Oropharyngeal Neoplasms | Laryngeal NeoplasmsUnited States
-
Shanghai Proton and Heavy Ion CenterNot yet recruitingRecurrent Nasopharyngeal Carcinoma
-
University of OklahomaMidwest Medical IsotopesTerminatedBrain TumorUnited States
-
The Catholic University of KoreaCompletedAcute Myeloid LeukemiaKorea, Republic of