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NCT02995902 Clinical Trial

FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

— SIBES II  

Official title:
FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02995902
Other study ID # 307_14
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 11, 2014
Est. completion date February 8, 2018

Study information
Verified date May 2022
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date February 8, 2018
Est. primary completion date February 8, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• FLT-PET

• MRI

Locations
Country Name City State
Denmark Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Christensen TN, Langer SW, Villumsen KE, Johannesen HH, Löfgren J, Keller SH, Hansen AE, Kjaer A, Fischer BM. (18)F-fluorothymidine (FLT)-PET and diffusion-weighted MRI for early response evaluation in patients with small cell lung cancer: a pilot study. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival 1 year
Primary Disease free survival 1 year
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