Back to resultsFLT-PET for Early Detection of Relapse in Patients With Irradiated Lung Cancer
Primary Purpose
Lung Cancer, Nonsmall Cell, Small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
FLT-PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer, Nonsmall Cell
Eligibility Criteria
Inclusion Criteria:
- history with lung cancer, small cell or non-small cell
- radiotherapy of lung cancer ended within the last 24 months
- radiotherapy might be normofractionated or stereotactic
- current suspicion of relapse
- written and oral consent
Exclusion Criteria:
- communication difficulties
- pregnancy or lactation
Sites / Locations
- Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
- Dept. Respiratory Medicine, Bispebjerg University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FLT-PET
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with local and/or regional relapse
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02995889
Brief Title
FLT-PET for Early Detection of Relapse in Patients With Irradiated Lung Cancer
Official Title
FLT-PET for Early Detection of Relapse in Patients With Irradiated Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 7, 2019 (Actual)
Study Completion Date
February 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. Study Description
Brief Summary
This study investigates the feasibility of FLT-PET to improve the diagnosis of relapse in patients with irradiated lung cancer in comparison with FDG-PET/CT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Nonsmall Cell, Small Cell Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FLT-PET
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
FLT-PET
Primary Outcome Measure Information:
Title
Number of patients with local and/or regional relapse
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
history with lung cancer, small cell or non-small cell
radiotherapy of lung cancer ended within the last 24 months
radiotherapy might be normofractionated or stereotactic
current suspicion of relapse
written and oral consent
Exclusion Criteria:
communication difficulties
pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Kjær, MD phD MDSci
Organizational Affiliation
Dept of Clinical Physiology, Nuclear medicine and PET, Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Dept. Respiratory Medicine, Bispebjerg University Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
33037090
Citation
Christensen TN, Langer SW, Persson G, Larsen KR, Loft A, Amtoft AG, Berthelsen AK, Johannesen HH, Keller SH, Kjaer A, Fischer BM. 18F-FLT PET/CT Adds Value to 18F-FDG PET/CT for Diagnosing Relapse After Definitive Radiotherapy in Patients with Lung Cancer: Results of a Prospective Clinical Trial. J Nucl Med. 2021 May 10;62(5):628-635. doi: 10.2967/jnumed.120.247742. Epub 2020 Oct 9.
Results Reference
result
PubMed Identifier
33670242
Citation
Christensen TN, Langer SW, Persson G, Larsen KR, Amtoft AG, Keller SH, Kjaer A, Fischer BM. Impact of [18F]FDG-PET and [18F]FLT-PET-Parameters in Patients with Suspected Relapse of Irradiated Lung Cancer. Diagnostics (Basel). 2021 Feb 11;11(2):279. doi: 10.3390/diagnostics11020279. Erratum In: Diagnostics (Basel). 2022 Jul 18;12(7):
Results Reference
result
Learn more about this trial
FLT-PET for Early Detection of Relapse in Patients With Irradiated Lung Cancer
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