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

May 3, 2022 updated by: Tine Nøhr Christensen, Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FLT-PET/MRI
Device: MRI
Device: FLT-PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 1 year
1 year
Disease free survival
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 11, 2014

Primary Completion (ACTUAL)

February 8, 2017

Study Completion (ACTUAL)

February 8, 2018

Study Registration Dates

First Submitted

December 9, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (ESTIMATE)

December 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307_14

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.

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