NCT02995902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2018

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

2.2 years

First QC Date

December 9, 2016

Last Update Submit

May 3, 2022

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    1 year

  • Disease free survival

    1 year

Study Arms (1)

FLT-PET/MRI

EXPERIMENTAL
Device: FLT-PETDevice: MRI

Interventions

FLT-PETDEVICE
FLT-PET/MRI
MRIDEVICE
FLT-PET/MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • biopsy proven small cell lung cancer
  • referred for standard chemotherapy
  • oral and written informed consent

You may not qualify if:

  • metal or electronical devices in the body not compatible with MRI of brain or thorax
  • pregnancy or lactation
  • communication difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34191195RESULT

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Andreas Kjær, MD phD MDSci

    Dept of Clinical Physiology, Nuclear medicine and PET, Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, research fellow

Study Record Dates

First Submitted

December 9, 2016

First Posted

December 19, 2016

Study Start

December 11, 2014

Primary Completion

February 8, 2017

Study Completion

February 8, 2018

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations

DK(1)