Back to resultsFLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer (SIBES II)
Primary Purpose
Small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
FLT-PET
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- biopsy proven small cell lung cancer
- referred for standard chemotherapy
- oral and written informed consent
Exclusion Criteria:
- metal or electronical devices in the body not compatible with MRI of brain or thorax
- pregnancy or lactation
- communication difficulties
Sites / Locations
- Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FLT-PET/MRI
Arm Description
Outcomes
Primary Outcome Measures
Overall survival
Disease free survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02995902
Brief Title
FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer
Acronym
SIBES II
Official Title
FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 11, 2014 (Actual)
Primary Completion Date
February 8, 2017 (Actual)
Study Completion Date
February 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to determine the value of FLT-PET early after initiated chemotherapy in patients with small cell lung cancer, and to determine whether MRI of the brain should be performed routinely in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FLT-PET/MRI
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
FLT-PET
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
1 year
Title
Disease free survival
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
biopsy proven small cell lung cancer
referred for standard chemotherapy
oral and written informed consent
Exclusion Criteria:
metal or electronical devices in the body not compatible with MRI of brain or thorax
pregnancy or lactation
communication difficulties
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
34191195
Citation
Christensen TN, Langer SW, Villumsen KE, Johannesen HH, Lofgren J, Keller SH, Hansen AE, Kjaer A, Fischer BM. 18F-fluorothymidine (FLT)-PET and diffusion-weighted MRI for early response evaluation in patients with small cell lung cancer: a pilot study. Eur J Hybrid Imaging. 2020 Jan 27;4(1):2. doi: 10.1186/s41824-019-0071-5.
Results Reference
result
Learn more about this trial
FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer
We'll reach out to this number within 24 hrs